DESTINATION 54-84501Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00389701009414), received between Dec 11, 2017 and Sep 11, 2023 — classified as 5 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT THE INVOLVED DESTINATION EX GUIDING SHEATH WAS USED IN EVT FOR A DIFFUSE LESION FROM L-CFA TO SFA. THE GUIDING SHEATH WAS DELIVERED UP TO THE LESION VIA RETROGRADE APPROACH WITHOUT PROBLEMS. A GUIDEWIRE WAS THEN INSERTED INTO THE GUIDING SHEATH, BUT RESISTANCE WAS FELT. WHEN THE GUIDING SHEATH WAS REMOVED FROM THE PATIENT, A KINK WAS NOTED IN THE GUIDING SHEATH. THE GUIDING SHEATH WAS NOT USED AND WAS REPLACED WITH ANOTHER GUIDING SHEATH, WHICH WAS USED WITHOUT KINKING. SUBSEQUENTLY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO HEALTH DAMAGES. ESTIMATED BLOOD LOSS WAS LESS 250CC'S.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17717161 ↗
• MalfunctionOct 23, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT THE INVOLVED DESTINATION DEVICE DILATOR DID NOT ATTACH TO THE INTRODUCER AND RETRACT WHEN ENTERING THE PATIENT. THE PATIENT WAS NOT INJURED DURING THE EVENT AND MEDICAL OR SURGICAL INTERVENTION WAS NOT REQUIRED. THE EVENT OCCURRED INTRA-OPERATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15656543 ↗
• MalfunctionNov 19, 2020Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE WHEN THE DESTINATION GUIDING SHEATH WAS TAKEN FROM THE PACKAGE, THE SHEATH WAS ALREADY KINKED. 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. 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 10868838 ↗
• MalfunctionNov 16, 2020Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE RIGHT FEMORAL ARTERY WAS PUNCTURED AND A DESTINATION GUIDEWIRE (EXTRA-STIFF 0.035INCH, 180CM, COOK MEDICAL) WAS INSERTED. WHEN THE GUIDING SHEATH WAS ATTEMPTED TO BE INSERTED, THE TIP OF THE GUIDING SHEATH WAS STUCK AND WAS UNABLE TO BE INSERTED. THE PATIENT HAD AS (AORTIC VALVE STENOSIS) AND CALCIFICATION OF THE VESSELS. AFTER SEVERAL ATTEMPTS OF INSERTION, THE GUIDING SHEATH COULD NOT BE INSERTED AND WAS REMOVED. THE TIP OF THE GUIDING SHEATH WAS FOUND TO BE DEFORMED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10846940 ↗
• MalfunctionAug 27, 2020Difficult to Insert; Difficult to Insert

  THE USER FACILITY REPORTED THAT THE DOCTOR WAS PERFORMING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) /ATHERECTOMY. WHEN HE TRIED TO ADVANCE THE DESTINATION SHEATH, HE NOTICED THE MISSHAPED TIP THAT WAS PREVENTING HIM FROM ADVANCING. HE REMOVED THE SHEATH AND GRABBED ANOTHER DESTINATION AND COMPLETED THE CASE SUCCESSFULLY. THE PATIENT WAS FINE AFTER THE PROCEDURE. THE PROCEDURE WAS SUCCESSFUL. THE BLOOD LOSS WAS LESS THAN 250CC'S. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 06AUG2020: IT WAS REPORTED THAT THERE WERE TWO SHEATHS THAT HAD THE DAMAGE OCCUR DURING AN ATTEMPT TO ADVANCE, THERE WAS A SKIN NICK MADE WITH A BLADE. THEY WERE UNABLE TO ADVANCE AND SAID THAT THEY HAD AN ISSUE WITH THE SHEATHS. THEY WERE EVENTUALLY ABLE TO ADVANCE A THIRD SHEATH. ADDITIONAL INFORMATION WAS RECEIVED ON 07AUG2020: BLOOD LOSS WAS LESS THAN 30ML'S. THE PROCEDURE WAS SUCCESSFUL WITH THE THIRD DESTINATION SHEATH AND IT WAS ABLE TO BE ADVANCED. THE PATIENT CONDITION WAS AS EXPECTED. THE PROCEDURE WAS A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA)/ATHERECTOMY OF RIGHT SFA (SUPERFICIAL FEMORAL ARTERY).

  Patient problems: Blood Loss

  MAUDE report 10463644 ↗
• InjuryAug 6, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  A DESTINATION SAMPLE WAS RECEIVED ON JUNE 26, 2020. ON JULY 15, 2020 THE USER FACILITY REPORTED THAT THE DESTINATION DILATOR SPLIT DURING ADVANCEMENT. THE PROCEDURE WAS FILTER RETRIEVAL. THE PATIENT WAS IN STABLE CONDITION. THEY SWITCHED TO A COOK DEVICE TO COMPLETE THE PROCEDURE SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10373868 ↗
• MalfunctionJul 16, 2020Difficult to Insert; Difficult to Insert

  THE USER FACILITY REPORTED THAT THE DOCTOR WAS PERFORMING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). /ANTHERECTOMY. WHEN HE TRIED TO ADVANCE THE DESTINATION SHEATH, HE NOTICED THE MISSHAPED TIP THAT WAS PREVENTING HIM FROM ADVANCING. HE REMOVED THE SHEATH AND GRABBED ANOTHER DESTINATION AND COMPLETED THE CASE SUCCESSFULLY. THE PATIENT WAS FINE AFTER THE PROCEDURE. THE PROCEDURE WAS SUCCESSFUL. THE BLOOD LOSS WAS LESS THAN 250CC'S. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED.

  Patient problems: Blood Loss

  MAUDE report 10284990 ↗
• MalfunctionJun 26, 2020Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE DESTINATION DEVICES WAS USED DURING A UP AND OVER LEG INTERVENTION, AND THE SHEATH KINKED. THE PROCEDURE WAS COMPLETED, AND THE PATIENT'S CONDITION WAS STABLE. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10199752 ↗
• InjuryFeb 6, 2020Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE DESTINATION SLENDER DEVICE VALVE CAME OFF OR UNSCREWED DURING THE PROCEDURE AND RESULTED IN 500 CC OF BLOOD LOSS. VALVE WAS TIGHTENED DURING PREP AND INSERTION. BLOOD LOSS WAS NOT OBSERVED UNTIL POOLING AND DRIPPING OF BLOOD BECAUSE IT WAS UNDER A TOWEL. PATIENT RECEIVED A TRANSFUSION OF TWO UNITS OF BLOOD. THE PATIENT WAS STABLE IN ICU. THE PROCEDURE WAS ABORTED DUE TO THE BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED 09JANUARY2019: THE PROCEDURE WAS A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR).

  Patient problems: Blood Loss

  MAUDE report 9676305 ↗
• MalfunctionSep 12, 2019Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE INVOLVED DESTINATION WAS INSERTED OVER A 260CM .035 GLIDEWIRE ADVANTAGE GA3502. THE SHEATH WAS INSERTED WITHOUT INCIDENT AND WHEN THE DILATOR WAS REMOVED, EXCESSIVE LEAKAGE WAS NOTICED COMING OUT OF THE CROSS-CUT VALVE. THE MD INSERTED A DILATOR SEVERAL TIMES TO "RESET THE VALVE". THEY THEN REMOVED THE VALVE AND REPLACED IT WITH A VALVE FROM 54-74501. THE ACCESS WAS THE RIGHT GROIN. THE CASE WAS COMPLETED WITHOUT INCIDENT. BLOOD LOSS WAS REPORTED TO BE LESS THAN 20CC. THERE WAS NO HARM TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT AND THE PATIENT LEFT THE FACILITY WITH NO COMPLICATIONS. THE OUTCOME OF THE PROCEDURE WAS EXCELLENT. ADDITIONAL INFORMATION WAS RECEIVED ON 22AUG2019. THE PROCEDURE WAS A LEFT LEG INTERVENTION AND ACCESS WAS OBTAINED VIA RIGHT FEMORAL ARTERY. THE SHEATH WAS INTRODUCED VIA RIGHT AND OVER THE ILIAC BIFURCATION TO THE LEFT LEG.

  Patient problems: Blood Loss

  MAUDE report 9009328 ↗
• InjuryJul 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT THE PATIENT WAS NOTED TO HAVE AN EXPANDING GROIN HEMATOMA AFTER REMOVAL OF THE DESTINATION SHEATH. DESPITE MANUAL PRESSURE, THIS CONTINUED SO A CT SCAN WAS DONE WHICH SHOWED CONTINUED ARTERIAL BLEEDING. PATIENT WAS KEPT IN HOSPITAL FOR TWO EXTRA NIGHTS TO MONITOR THE HEMATOMA WITH NO FURTHER INTERVENTION PERFORMED. A TERUMO INTRODUCER WAS USED FOR THE PUNCTURE. IT HAS BEEN ALLEGED THAT THE HEMATOMA/BLEEDING WAS DUE TO THE INTRODUCER. HEMOSTASIS WAS ACHIEVED IN THE LAB. THE HEMATOMA WAS LOCATED ON THE RIGHT SIDE. THE PATIENT WAS DISCHARGED IN STABLE CONDITION.

  Patient problems: Blood Loss; Hematoma

  MAUDE report 8784809 ↗
• InjuryJun 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT A PHYSICIAN COMPLAINED OF BLEEDING IN LEFT GROIN ACCESS, AND HEMATOMA FORMATION AROUND THE SHEATH DURING A CTO CORONARY PROCEDURE. POST PROCEDURE COMPLICATION OCCURRED. THE PATIENT HAS BEEN DISCHARGED. INDEX PROCEDURE OUTCOME WAS SATISFACTORY. THE PROCEDURES PERFORMED WERE A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO THE RIGHT CORONARY ARTERY (RCA) WITH DRUG-ELUTING STENTS AND A PCI TO THE CTO OF THE CIRCUMFLEX VESSEL WITH DRUG-ELUTING STENTS AND A MODERATE SEDATION. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THE PATIENT WAS REPORTED TO BE STABLE CONDITION. THE PROCEDURE OUTCOME WAS SATISFACTORY. "DESCRIPTION OF PROCEDURE: AFTER INFORMED CONSENT WAS OBTAINED, THE PATIENT WAS BROUGHT TO THE CATH LAB. WE PREPPED BOTH GROINS. MODERATE SEDATION: THE PATIENT RECEIVED FENTANYL AND VERSED FOR SEDATION. HIS HEART RATE, BLOOD PRESSURE, O2 SATS WERE CONTINUOUSLY MONITORED BY INDEPENDENTLY TRAINED OBSERVER. FACE-TO-FACE TIME FOR PROCEDURE IS 1.5 HOURS. A 8X45CM SHEATH WAS PLACED IN BOTH GROINS, PRE-CLOSED WITH PERCLOSE DEVICES. WE THEN PLACED AN EBU 3.5 GUIDE WITH SIDE HOLES TO THE LEFT MAIN 8FR AND AL 0.75 WITH SIDE HOLES 8FR TO THE RCA. SIMULTANEOUS INJEC

  Patient problems: Blood Loss; Hematoma; Pleural Effusion; Pseudoaneurysm

  MAUDE report 8741661 ↗
• MalfunctionOct 30, 2018Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THEY WERE USING AN 8FR 45CM DESTINATION, DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE. THE PROCEDURE WENT WELL AND THEY SENT THE PATIENT TO RECOVERY WITH THE DESTINATION, AND THE UNKNOWN CATHETER STILL IN PLACE. THEY WERE WAITING ON PATIENT'S ACTIVATED COAGULATION TIME (ACT) LEVELS TO GO DOWN, AND A VCD WAS NOT GOING TO BE USED. WHEN THE PATIENT WAS IN RECOVERY HIS LEG WENT COLD, THEY TOOK HIM BACK TO THE OPERATING ROOM LATER THAT AFTERNOON AND NOTICED THAT THERE WAS SOME LEAKING. ONE OF THE NURSES FLUSHED THE SHEATH AND CATHETER AND SAW THAT THE SHEATH WAS LEAKING AND HAD SOME CRACKS, AND PIN SIZE HOLES. THEY THEN REMOVED THE DESTINATION AND ENTERED A NEW DESTINATION, AND THEY THEN NOTICED THAT THE NEW ONE WAS ALSO LEAKING. THEY WERE ABLE TO COMPLETE THE LEG INTERVENTION AND SAVE THE PATIENT'S LEG. THE PATIENT RECOVERED AND WAS IN GOOD AND STABLE CONDITION AFTERWARDS. THE BLOOD LOSS WAS LESS THAN 250CC'S. THE PROCEDURE OUTCOME WAS REPORTED TO BE GOOD.

  Patient problems: Blood Loss

  MAUDE report 8020962 ↗
• InjuryOct 30, 2018Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THEY WERE USING AN 8FR 45CM DESTINATION, DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE. THE PROCEDURE WENT WELL AND THEY SENT THE PATIENT TO RECOVERY WITH THE DESTINATION, AND THE UNKNOWN CATHETER STILL IN PLACE. THEY WERE WAITING ON PATIENT'S ACTIVATED COAGULATION TIME (ACT) LEVELS TO GO DOWN, AND A VCD WAS NOT GOING TO BE USED. WHEN THE PATIENT WAS IN RECOVERY HIS LEG WENT COLD, THEY TOOK HIM BACK TO THE OR LATER THAT AFTERNOON AND NOTICED THAT THERE WAS SOME LEAKING. ONE OF THE NURSES FLUSHED THE SHEATH AND CATHETER AND SAW THAT THE SHEATH WAS LEAKING AND HAD SOME CRACKS, AND PIN SIZE HOLES. THEY THEN REMOVED THE DESTINATION AND ENTERED A NEW DESTINATION, AND THEY THEN NOTICED THAT THE NEW ONE WAS ALSO LEAKING. THEY WERE ABLE TO COMPLETE THE LEG INTERVENTION AND SAVE THE PATIENT'S LEG. THE PATIENT RECOVERED AND WAS IN GOOD AND STABLE CONDITION AFTERWARDS. THE BLOOD LOSS WAS LESS THAN 250CC'S. THE PROCEDURE OUTCOME WAS REPORTED TO BE GOOD.

  Patient problems: Blood Loss

  MAUDE report 8020959 ↗
• MalfunctionDec 11, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THEY WERE UNABLE TO INSERT THE LOCATOR WITH THE INVOLVED ANGIO-SEAL DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER: THE VALVE WOULD NOT STAY SECURE ON THE SHEATH. THE SHEATH WAS NEVER INSERTED INTO THE PATIENT. THE MALFUNCTION WAS NOTICED WHEN PREPPING THE SHEATH AND THEREFOR NEVER USED. ANOTHER 8 FR DESTINATION WAS OPENED AND USED SUCCESSFULLY. THERE WAS NO BLOOD LOSS AND THE PATIENT WAS STABLE. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7103712 ↗