DESTINATION RSP01Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00389701007786), received between Jun 5, 2018 and Dec 13, 2022 — classified as 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryDec 13, 2022Break; Difficult to Remove; Break; Difficult to Remove

  THE USER FACILITY REPORTED THAT THE INVOLVED DESTINATION DEVICE INTRODUCER WAS WITHDREW WHEN THE OPERATOR HAD MAJOR DIFFICULTIES DESPITE THE IMPLEMENTATION A RIGID GUIDE TO FACILITATE THE REMOVAL. A SIGNIFICANT ELONGATION WAS NOTED ON THE DEVICE WHICH FRAYED AT THE LEVEL OF THE SKELETON METAL, AND WHICH ENDED UP BREAKING IN THE PATIENT'S ARTERY. CLINICAL CONSEQUENCES AND STATUS OF THE PATIENT INVOLVED WAS NEED FOR A CONVERSION TO HAVE OPEN SURGERY BY APPROACHING THE SCARPA ON THE RIGHT. SIMPLE FOLLOW-UP ACTIONS TAKEN FOR THE PATIENT IN RELATION TO THE DM. THE TIP OF THE INTRODUCER WITH THE ENTIRE METAL SKELETON WAS REMOVED WITHOUT DIFFICULTY WITH FORCEPS. THE PATIENT CONDITION WAS NOT HARMED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15971696 ↗
• MalfunctionAug 4, 2022Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  THE USER FACILITY REPORTED THAT THE DESTINATION DEVICE INVOLVED DILATOR WOULD NOT ADVANCE INTO THE SHEATH FULLY. IT WOULD GET CAUGHT ROUGHLY HALFWAY THROUGH THE SHEATH. ANOTHER SHEATH WAS REPORTED, AND THE DILATOR WOULD NOT ADVANCE INTO THE SHEATH FULLY. IT WOULD GET CAUGHT ROUGHLY HALFWAY THROUGH THE SHEATH. THEN A THIRD SHEATH WAS OPENED, AND THE SAME THING HAPPENED. THE DOCTOR CUT THE SHEATH OPENED TO SEE WHAT WAS GOING ON AND STATED THAT THE COIL REINFORCING HAD SOME SORT OF KINK/DAMAGE TO IT. BOTH SHEATHS THAT WERE OPENED WITH THE SAME AND WERE NOT USED. THE THIRD SHEATH WAS OPENED AND THERE WAS NO ISSUE WITH IT, AND THE CASE WAS COMPLETED SUCCESSFULLY. BLOOD LOSS WAS LESS THAN 250CC'S. THE PATIENT RECOVERED. THE EVENT OCCURRED INTRA-OPERATIVE. THE PATIENT WAS NOT INJURED, AND MEDICAL OR SURGICAL INTERVENTION WAS NOT REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 18 JUL 2022: THE PROCEDURE PERFORMED WAS A PERIPHERAL ARTERY DISEASE (PAOD) ANGIOGRAM AND TREATMENT OF THE LEFT LEG. THE PATIENT CONDITION WAS STABLE AT THE END OF THE PROCEDURE, AS THEY OPENED A THIRD DEVICE, AND IT WAS FUNCTIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15168937 ↗
• InjuryJul 14, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED ON 16AUG2021. THERE WAS NO SCAR TISSUE OR SPASM NOTED DURING THE DESTINATION SHEATH INSERTION. THE VESSEL WAS HEAVILY CALCIFIED AND TORTUOUS AS NOTED AND HAD A LOT OF RESISTANCE DURING INSERTION OF THE SHEATH. AN ES GUIDE WIRE WAS PLACED INTO THE DISTAL PORTION OF THE LEG. PRIOR TO TRYING TO WITHDRAW OF THE DESTINATION SHEATH. HE DID MEET A LOT OF RESISTANCE WHILE TRYING OF TAKE THE SHEATH OUT OF THE ILIAC. THEY DID CONTINUE TO TRY TO REMOVE THE SHEATH WITH RESISTANCE. THERE WAS NO SPASM SHOWN DURING WITHDRAW OF THE SHEATH. THE BALLOON WAS PLACED INSIDE THE SHEATH BUT WAS NOT INFLATED IN THE SHEATH. THE DOCTOR INDICATED THAT THEY WERE GOING TO USE THE BALLOON AS AN ANCHOR AND PULL THE SHEATH AND BALLOON OUT TOGETHER HOWEVER DECIDED AGAINST THAT TECHNIQUE. IT WAS THEN THOUGHT THEY COULD USE IT A WAY TO CONTROL BLEEDING IF THINGS GOT OUT OF CONTROL.

  Patient problems: Insufficient Information

  MAUDE report 12165798 ↗
• MalfunctionJun 21, 2021Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE DESTINATION SHEATH HAD A BOW IN IT WHEN IT ARRIVED. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT WAS IN STABLE CONDITION AND THE PROCEDURE OUTCOME WAS GOOD. ADDITIONAL INFORMATION WAS RECEIVED ON 26MAY2021. THE DEVICE WAS NOT USED. THE DAMAGE WAS NOTED WHILE THEY WERE PREPPING IT. THE ISSUE WAS A KINK IN THE SHEATH, THE DILATOR WOULD NOT GO THROUGH THE SHEATH. THIS WAS A BELOW THE KNEE FIX. A NEW DESTINATION SHEATH AND A MEDTRONIC BALLOON WERE USED. THE PATIENT WAS IN THE ROOM HOWEVER THE ISSUE WAS NOTED DURING PREP AND IT NEVER ENTERED THE PATIENT. HEMOSTASIS WAS ACHIEVED BY AN ANGIO-SEAL DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12033688 ↗
• MalfunctionFeb 22, 2021Break; Break

  THE USER FACILITY REPORTED THAT THE DESTINATION SHEATH VALVE (HUB) WAS DAMAGED AND SEPARATED. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL AND COMPLETE. ADDITIONAL INFORMATION WAS RECEIVED ON 01FEB2021. THE DAMAGE WAS CAUGHT PRIOR TO USE AND A SECOND SHEATH WAS OPENED AND USED TO COMPLETE THE PROCEDURE SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11363074 ↗
• MalfunctionDec 2, 2020Break; Break

  THE USER FACILITY REPORTED THAT PART OF A DESTINATION SHEATH BROKE DURING A PROCEDURE EVERYTHING WENT WELL WITH THE CASE BEYOND THAT AND THERE WAS NO ADVERSE EVENT WITH THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10934308 ↗
• InjuryJul 17, 2020Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THE DESTINATION DEVICE HAD MULTIPLE KINKS/SMASHED. THE PATIENT CONDITION WAS GOOD. THE OUTCOME OF THE PROCEDURE WAS GOOD. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 26JUNE2020: THE TYPE OF THE PROCEDURE WAS A PERIPHERAL LEG CASE. THE PROCEDURE WAS COMPLETED USING ANOTHER DESTINATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10292567 ↗
• InjuryJul 17, 2020Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THE DESTINATION DEVICE HAD MULTIPLE KINKS/SMASHED. THE PATIENT CONDITION WAS GOOD. THE OUTCOME OF THE PROCEDURE WAS GOOD. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED.ADDITIONAL INFORMATION WAS RECEIVED ON 26JUNE2020: THE TYPE OF THE PROCEDURE WAS A PERIPHERAL LEG CASE. THE PROCEDURE WAS COMPLETED USING ANOTHER DESTINATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10292513 ↗
• MalfunctionJun 12, 2020Material Deformation; Material Deformation

  THIS REPORT HAS BEEN DEEMED REPORTABLE BASED UPON THE EVALUATION OF THE ACTUAL DEVICE. THE USER FACILITY REPORTED AN UNKNOWN ISSUE WITH THE DESTINATION DILATOR TIP. THE PROCEDURE WAS SUCCESSFUL. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PATIENT'S CONDITION WAS STABLE. ADDITIONAL INFORMATION WAS RECEIVED ON 05MAY2020. THE REPORTED ISSUE WAS NOTICED DURING PREP WITH THE PATIENT PRESENT. THEY OPENED ANOTHER RSP01 AND FINISHED THE PROCEDURE SUCCESSFULLY. THE PROCEDURE WAS A PERIPHERAL DIAGNOSTIC CATH. ADDITIONAL INFORMATION WAS RECEIVED 10JUN2020. IT WAS THE TIP OF THE SHEATH, NOT THE DILATOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10148637 ↗
• InjuryJun 5, 2018Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED ON 6/5/18: THE PATIENT HAD PREVIOUS SURGERIES IN THE GROIN AREA. SCAR TISSUE WAS PRESENT. THE PHYSICIAN STARTED WITH A 5FR DIAGNOSTIC SHEATH AND THEN SWITCHED TO THE 65CM DESTINATION. THE DESTINATION WAS TIGHT ON INSERTION DUE TO THE SCAR TISSUE. VESSEL CHARACTERISTICS: MODERATE TORTUOSITY. NO CALCIUM PRESENT IN THE AREA OF THE DESTINATION. THE ACCESS SITE WAS RIGHT SIDE CONTRALATERAL AND THE PROCEDURE WAS A LEFT LOWER EXTREMITY ANGIOPLASTY. THE PROCEDURE WAS PERFORMED. AT THE END OF THE CASE, THE PHYSICIAN WAS REMOVING THE DESTINATION OVER A STIFF GUIDEWIRE. AT FIRST THERE WAS A LITTLE RESISTANCE, THEN IT BECAME VERY EASY TO PULL BACK THE SHEATH. THE PHYSICIAN NOTICED THAT THE DESTINATION WAS UNRAVELING. THE PHYSICIAN CUT THE DESTINATION AT THE ENTRY SITE. SURGICAL INTERVENTION WAS PERFORMED. A CUT DOWN WAS PERFORMED ON BOTH GROINS AND ALL OF THE DESTINATION FRAGMENTS WERE REMOVED FROM THE PATIENT. THE PATIENT RECOVERED WELL AND WAS DISCHARGED 2 DAYS POST PROCEDURE.

  Patient problems: Blood Loss; No Code Available

  MAUDE report 7569131 ↗