DESTINATION 54-74501Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00389701008851), received between Apr 25, 2017 and Jun 2, 2025 — classified as 13 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (28 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• InjuryJun 2, 2025Break; Material Separation; Break; Material Separation

  THE USER FACILITY REPORTED THAT THE DESTINATION SHEATH BROKE OFF IN THE PATIENT DURING THE PROCEDURE AND HAD TO BE SNARED OUT BY THE DOCTOR. ACCESS WAS VIA GROIN. THERE WAS NO BLOOD LOSS. THE REPORTED EVENT DID RESULT IN PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 22125571 ↗
• MalfunctionDec 2, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  THE USER FACILITY REPORTED UPON OPENING THE DESTINATION SHEATH, THE TECH WENT TO TIGHTEN THE VALVE. THE VALVE WOULD NOT STAY TIGHT AND APPEARED TO UNSCREW ITSELF. AFTER MANY ATTEMPTS, ANOTHER DEVICE WAS OPENED, AND THE TECH EXPERIENCED THE SAME ISSUE. THE TECH APPLIED DERMABOND TO THE VALVE THREAD AND CONTINUED ON WITH THE CASE. THE SECOND DESTINATION WAS DISCARDED. THERE WAS NO BLOOD LOSS. THE PROCEDURE WAS AN ANGIOGRAPHY. THERE WAS NO PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20819772 ↗
• MalfunctionJul 25, 2024Material Separation; Unraveled Material; Material Separation; Unraveled Material

  THE USER FACILITY REPORTED THAT WHEN FINISHING A LEG ANGIOGRAM, UPON REMOVAL OF THE SHEATH, THE DEVICE BEGAN TO UNRAVEL, AND THE HUB BROKE AWAY FROM THE BODY OF THE SHEATH. THEY WERE ABLE TO RETRIEVE THE REMAINING PORTION OF THE SHEATH AND THERE WAS NO BLOOD LOSS. THE PATIENT LEFT THE LAB IN STABLE CONDITION WITH NO IMMEDIATE COMPLICATIONS. THE PATIENT DID HAVE MULTIPLE PREVIOUS SURGERIES AT THE ACCESS SITE. THERE WAS NO PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 28JUN2024: THEY WERE ABLE TO REMOVE THE SHEATH THAT BROKE AWAY. THE PHYSICIAN REPORTED THE PREVIOUS SURGERIES AT THE ACCESS SITE, LIKELY CONTRIBUTED TO THE ISSUE AFTER TORTUOUS SCAR TISSUE WAS ENCOUNTERED AT THE ACCESS SITE UPON REMOVAL OF THE SHEATH. NO ADDITIONAL DEVICES OR EQUIPMENT WERE USED WITH THE REPORTED PRODUCT.

  Patient problems: Foreign Body In Patient

  MAUDE report 19827692 ↗
• InjuryJul 28, 2021Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT DURING A CROSSOVER APPROACH FROM THE RIGHT INGUINAL REGION, WHEN DESTINATION GUISING SHEATH WAS ATTEMPTED TO BE DELIVERED TO THE BIFURCATION OF SFA (SUPERFICIAL FEMORAL ARTERY) AND DFA, THE GUIDING SHEATH WOULD NOT GO THROUGH. THE GUIDING SHEATH WAS ONCE WITHDRAWN AND SUCCESSFULLY REMOVED FROM THE PATIENT. WHEN THE DEVICE WAS CHECKED, A KINK WAS OBSERVED IN THE DILATOR. THE GUIDING SHEATH WAS NOT USED AND REPLACED WITH A COMPETITOR'S GUIDING SHEATH TO CONTINUE THE PROCEDURE. SUBSEQUENTLY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ESTIMATED BLOOD LOSS WAS LESS THAN 250CC'S. THERE WAS NO HEALTH DAMAGE TO THE PATIENT. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12240276 ↗
• MalfunctionJul 25, 2021Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  THE USER FACILITY REPORTED THAT THE DESTINATION GUIDING SHEATH WAS UNABLE TO GO THROUGH THE MEANDERING ARTERY THAT WAS NARROW DUE TO CALCIFICATION. SEVERAL ATTEMPTS WERE MADE; HOWEVER, THE END OF THE DILATOR TIP WAS KINKED PROBABLY DUE TO INSUFFICIENT STRENGTH. NO FURTHER THRUST WAS TRANSMITTED, AND THE GUIDING SHEATH WAS UNABLE TO GO THROUGH THE ARTERY. THE GUIDING SHEATH WAS NOT USED AND REPLACED WITH ANOTHER GUIDING SHEATH TO CONTINUE THE PROCEDURE. SUBSEQUENTLY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THERE WAS NO HEALTH DAMAGE TO THE PATIENT. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12223186 ↗
• MalfunctionJun 15, 2021Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE DESTINATION DEVICE TIP WAS DEFORMED. AFTER THE RIGHT FEMORAL ARTERY WAS PUNCTURED, THE GUIDING SHEATH WAS INSERTED FROM THE PUNCTURE SITE, ALTHOUGH THE TIP OF THE SHEATH WAS DEFORMED AND WAS DIFFICULT TO BE INSERTED IN THE ARTERY. THE GUIDING SHEATH WAS NOT USED AND REPLACED WITH ANOTHER GUIDING SHEATH, WHICH WAS INSERTED IN THE ARTERY WITHOUT PROBLEM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY CONTRALATERAL APPROACH. THERE WAS NO HEALTH DAMAGE TO THE PATIENT. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11999675 ↗
• MalfunctionJun 15, 2021Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE TIP OF THE DESTINATION SHEATH WAS DEFORMED. UPON ATTEMPTING TO APPROACH FROM THE LEFT FEMORAL ARTERY USING THE DESTINATION EX GUIDING SHEATH, THE GUIDING SHEATH WAS UNABLE TO BE INSERTED DUE TO THE DEFORMATION ON THE TIP. THE GUIDING SHEATH WAS NOT USED AND REPLACED WITH ANOTHER GUIDING SHEATH OF THE SAME SIZE, WHICH WAS INSERTED WITHOUT INCIDENT. AFTER THAT, THE LESION WAS DILATED USING A BALLOON AND A STENT WAS IMPLANTED. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THERE WAS NO HEALTH DAMAGE TO THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11999586 ↗
• MalfunctionJun 11, 2021Material Deformation; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED ON 12JULY2021: IT WAS CONFIRMED THAT THE SHEATH OF THE DESTINATION WAS KINKED. THE GUIDEWIRE WAS FINE. NO DAMAGE WAS NOTICED ON THE SHEATH PRIOR TO INSERTION OF THE PATIENT'S BODY. THE PATIENT'S ANATOMY WAS NOT TORTUOUS OR CALCIFIED AND NO SCAR TISSUE PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11982222 ↗
• MalfunctionJun 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT WHEN THE NURSE OPENED DESTINATION DEVICE, THE REMOVABLE VALVE FELL ONTO THE FLOOR, IT APPEARED TO NOT BE ATTACHED PROPERLY TO DEVICE. THERE WAS NO AFFECT ON THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 16MAY2021. THEY OPENED ANOTHER DESTINATION GUIDING SHEATH TO CONTINUE THE PROCEDURE. THE PATIENT'S CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11928784 ↗
• MalfunctionMay 26, 2021Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE DESTINATION TIP OF THE GUIDING SHEATH WAS DEFORMED. WHEN THE GUIDING SHEATH WAS INSERTED INTO THE FEMORAL ARTERY, THE GUIDING SHEATH ENCOUNTERED HIGH RESISTANCE AND THE TIP OF THE GUIDING SHEATH BECAME DEFORMED. THE GUIDING SHEATH WAS NOT USED AND WAS REPLACED WITH ANOTHER GUIDING SHEATH TO CONTINUE THE PROCEDURE. SUBSEQUENTLY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO HEALTH DAMAGE TO THE PATIENT. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC'S. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11888776 ↗
• InjuryMay 19, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT WHEN THE DESTINATION EX GUIDING SHEATH WAS ATTEMPTED TO BE INSERTED, THE GUIDING SHEATH WAS DIFFICULT TO BE INSERTED DUE TO HIGH RESISTANCE, AND THE TIP OF THE SHEATH BECAME DEFORMED. THE GUIDING SHEATH WAS NOT USED AND REPLACED WITH A COMPETITOR'S PRODUCT, WHICH WAS INSERTED WITHOUT ANY PROBLEM. SUBSEQUENTLY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THERE WAS NO HEALTH DAMAGE TO THE PATIENT. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11850057 ↗
• MalfunctionApr 15, 2021Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THEY WERE UNABLE TO INSERT THE DESTINATION DEVICE INTO THE ARTERY. WHEN THE PHYSICIAN ATTEMPTED TO INSERT THE DESTINATION GUIDING SHEATH INTO THE ARTERY, THE PHYSICIAN FELT SOMETHING WAS CAUGHT AS THERE WAS A GAP BETWEEN THE DILATOR AND THE TIP OF THE GUISING SHEATH. THE GUIDING SHEATH WAS NOT USED AND REPLACED WITH ANOTHER GUIDING SHEATH TO CONTINUE THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. THERE WAS NO HEALTH DAMAGE FOR THE PATIENT. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11670576 ↗
• MalfunctionApr 8, 2021Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE INVOLVED DESTINATION WAS USED ON A PATIENT WITH AN ARTERY THAT WAS SEVERELY TORTUOUS AND CALCIFIED, IT WAS DIFFICULT TO INSERT THE DEVICE. THE DESTINATION GUIDING SHEATH WAS THEREFORE KINKED. THE GUIDING SHEATH WAS NOT USED AND REPLACED WITH ANOTHER GUIDING SHEATH TO CONTINUE THE PROCEDURE. SUBSEQUENTLY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE BLOOD LOSS WAS LESS THAN 250CC'S. THERE WAS NO HEALTH DAMAGE TO THE PATIENT. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11634180 ↗
• MalfunctionApr 8, 2021Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE WHEN THE DESTINATION GUIDING SHEATH GUIDEWIRE WAS ATTEMPTED TO BE ADVANCED, THE TIP OF THE GUIDING SHEATH WAS DEFORMED DUE TO SEVERE CALCIFICATION AROUND THE ILIAC ARTERY AND WAS NOT ADVANCED. THE GUIDING SHEATH WAS NOT USED AND REPLACED WITH ANOTHER GUIDING SHEATH TO CONTINUE THE PROCEDURE. SUBSEQUENTLY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO HEALTH DAMAGE TO THE PATIENT. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC'S. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11634005 ↗
• MalfunctionApr 8, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  THE USER FACILITY REPORTED THAT WHEN THE DESTINATION GUIDING SHEATH GUIDEWIRE WAS INSERTED INTO THE ARTERY, THE ILIAC ARTERY WAS CALCIFIED AND TORTUOUS. THE END OF THE GUIDING SHEATH WAS SPLIT FINELY. THE GUIDING SHEATH WAS NOT USED AND REPLACED WITH ANOTHER GUIDING SHEATH TO CONTINUE THE PROCEDURE. SUBSEQUENTLY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO HEALTH DAMAGE TO THE PATIENT. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11632710 ↗
• InjuryApr 2, 2021Difficult to Insert; Difficult to Insert

  THE USER FACILITY REPORTED THAT THE DESTINATION EX 7FR SHEATH WAS USED FOR A PLACEMENT OF A VIABAHN STENT GRAFT IN EXTERNAL ILIAC ARTERY (EIA). THE STENT GRAFT WAS DIFFICULT TO BE DELIVERED VIA THE GUIDING SHEATH, EVEN THOUGH IT USUALLY PASSES THROUGH. THE SIZE OF THE VIABAHN WAS UNKNOWN. THERE WAS NO KINK NOR OTHER ABNORMALITY OBSERVED IN THE SHEATH. THE GUIDING SHEATH WAS NOT USED AND REPLACED WITH A COMPETITOR'S GUIDING SHEATH TO CONTINUE THE PROCEDURE. SUBSEQUENTLY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO HEALTH DAMAGE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11609255 ↗
• MalfunctionMar 29, 2021Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THERE WAS A KINK IN THE DESTINATION GUIDING SHEATH. WHEN THE PHYSICIAN ATTEMPTED TO INSERT THE GUIDING SHEATH INTO THE ARTERY, THE GUIDING SHEATH ENCOUNTERED HIGH RESISTANCE AND KINKED. THE GUIDING SHEATH WAS NOT USED AND REPLACED WITH ANOTHER DESTINATION GUIDING SHEATH TO CONTINUE THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. THERE WAS NO HEALTH DAMAGE TO THE PATIENT. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11581738 ↗
• InjuryMar 8, 2021Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THERE WAS A KINK IN THE DESTINATION SHEATH. WHEN THE DESTINATION EX GUIDING SHEATH WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LOCATION USING CROSSOVER APPROACH FROM THE CONTRALATERAL SUPERFICIAL FEMORAL ARTERY (SFA), THE GUIDING SHEATH WAS KINKED DUE TO SEVERE CURVATURE OF THE BLOOD VESSEL. THE GUIDING SHEATH WAS NOT USED AND REPLACED WITH A COMPETITOR'S PRODUCT, WHICH WAS ADVANCED TO THE TARGET LOCATION WITHOUT PROBLEMS. SUBSEQUENTLY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THERE WAS NO HEALTH DAMAGE TO THE PATIENT. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11435585 ↗
• InjuryFeb 25, 2021Material Deformation; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED ON 19MAR2021. IT WAS CONFIRMED THAT THE DILATOR WAS PRESENT TOGETHER WITH THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11378686 ↗
• InjuryFeb 22, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE USER FACILITY REPORTED THAT THE DESTINATION EX GUIDING SHEATH WAS USED FOR ENDOVASCULAR THERAPY (EVT) OF THE LEFT COMMON ILIAC ARTERY. THE GUIDING SHEATH DID NOT ADVANCE IN THE LESION AND THE TIP OF THE DILATOR BECAME DEFORMED DUE TO SEVERE STENOSIS OF THE LESION. THE GUIDING SHEATH WAS NOT USED AND REPLACED WITH A COMPETITOR'S PRODUCT TO CONTINUE THE PROCEDURE. SUBSEQUENTLY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO HEALTH DAMAGE TO THE PATIENT. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11363079 ↗
• InjuryFeb 11, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT THE TIP OF THE DESTINATION SHEATH WAS DEFORMED. THE DEVICE WAS USED FOR A PATIENT WITH A CALCIFIED ARTERY. WHEN THE DESTINATION EX GUIDING SHEATH WAS INSERTED INTO THE ARTERY USING AN ANTEGRADE APPROACH AND SLIGHTLY PUSHED, RESISTANCE WAS FELT. THE GUIDING SHEATH WAS THEREFORE REMOVED AND SUCCESSFULLY REMOVED FROM THE PATIENT. A TIP OF THE GUIDING SHEATH WAS FOUND TO BE DEFORMED. THE GUIDING SHEATH WAS NOT USED AND REPLACED WITH A COMPETITOR'S GUIDING SHEATH THAT HAD BEEN PREPARED AS A BACKUP TO CONTINUE THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE COMPETITOR'S DEVICE. THERE WAS NO HEALTH DAMAGE TO THE PATIENT. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11313031 ↗
• InjuryFeb 5, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT WHEN THE DESTINATION SHEATH WAS INSERTED INTO THE ARTERY FOR THE PERCUTANEOUS PERIPHERAL INTERVENTION (PPI), RESISTANCE WAS FELT, AND THE TIP OF THE SHEATH WAS FOUND TO BE DEFORMED. THE DEVICE WAS NOT USED, AND A COMPETITOR'S SHEATH WAS USED TO CONTINUE THE PROCEDURE. SUBSEQUENTLY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THERE WAS NO HEALTH DAMAGE FOR THE PATIENT. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11290192 ↗
• MalfunctionJan 8, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT WHEN THE 7FR 45CM DESTINATION GUIDING SHEATH WAS INSERTED INTO AN ARTERY WITH SEVERE CALCIFICATION, THE TIP OF THE GUIDING SHEATH WAS DEFORMED DUE TO HIGH RESISTANCE. THE GUIDING SHEATH WAS NOT USED AND REPLACED WITH ANOTHER GUIDING SHEATH TO CONTINUE THE PROCEDURE. SUBSEQUENTLY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO HEALTH DAMAGE FOR THE PATIENT. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11141883 ↗
• InjuryNov 25, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT THE PHYSICIAN ATTEMPTED TO INSERT THE DESTINATION GUIDING SHEATH TO THE ARTERY AFTER THE DILATOR WAS SET TO THE GUIDING SHEATH, HOWEVER, IT WAS DIFFICULT TO INSERT THE GUIDING SHEATH DUE TO HIGH RESISTANCE. THE PHYSICIAN, THEREFORE, WITHDREW THE GUIDING SHEATH. THE TIP OF THE GUIDING SHEATH WAS FOUND TO BE DEFORMED, AND THIS MADE THE GUIDING SHEATH DIFFICULT TO BE INSERTED. THE GUIDING SHEATH WAS NOT USED, AND REPLACED WITH A COMPETITOR'S GUIDING SHEATH TO CONTINUE THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE BLOOD LOSS WAS LESS THAN 250CC'S. THERE WAS NO HEALTH DAMAGE TO THE PATIENT. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. THERE WERE NO OTHER DEVICES, OR EQUIPMENT USED WITH THE REPORTED PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10905717 ↗
• MalfunctionNov 1, 2020Difficult to Advance; Material Split, Cut or Torn; Difficult to Advance; Material Split, Cut or Torn

  THE USER FACILITY REPORTED THAT THE DESTINATION GUIDING SHEATH COULD NOT GO THROUGH THE LESION DUE TO SEVERE CALCIFICATION. THE PHYSICIAN WITHDREW THE GUIDING SHEATH. THE TIP OF THE GUIDING SHEATH WAS FOUND TO BE SPLIT FINELY. THE DEVICE WAS NOT USED AND REPLACED WITH ANOTHER DESTINATION EX GUIDING SHEATH TO CONTINUE THE PROCEDURE. SUBSEQUENTLY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO HEALTH DAMAGE FOR THE PATIENT. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10767821 ↗