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CP Stent™ 614307Recalls & reported problems

B Braun Interventional Systems, Inc · COVERED CP STENT 8Z 2.2CM · Class 3 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964898785), received between May 22, 2017 and May 22, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (1 report).

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

Device problems

  • Detachment Of Device Component1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 22, 2017Detachment Of Device Component

    AS REPORTED BY BRAUN: " CRIMPED ON TO BIB BALLOON, INSERTED TO SHEATH WITH THE HEMOSTASIS TOOL THE COVER CAME BACK AND ROLLED OFF. THIS HAPPENED TWO TIMES. WENT IN AND OUT OF THE HEMOSTASIS VALVE MULTIPLE TIMES PHYSICIAN RE-CRIMPED IT. ACCOUNT SAID IT COULD BE OPERATOR ERROR, PHYSICIAN'S FIRST TIME USING STENT UNAIDED. AS STENT WAS ADVANCING THROUGH, IT KEPT COMING OFF OF THE BALLOON. THERE WAS NO DIFFICULTY MOUNTING THE BALLOON. THE SIZE OF THE CATHETER THE STENT WAS MOUNTED ON: 16 MM X 4.5 CM BOTH, 2.2 STENT 3.4 STENT. BOTH SALINE AND CONTRAST MEDIA WERE USED DURING PREP. THE HEMOSTASIS TOOLS WERE USED THAT ARE PROVIDED BY NUMED - THE SIZES: 16 AND 18. THE STENT STARTED SLIPPING DURING INSERTION THROUGH THE SHEATH. THE INNER BALLOON WAS INFLATED BEFORE THE OUTER BALLOON ONCE THE 2 SUCCESSFUL STENTS WERE DEPLOYED. THEY ATTEMPTED TO PULL THE STENT BACK THROUGH THE HEMOSTASIS VALVE TO GET IT OUT. CRIMPING PROCESS USED: RING MANDRIL THROUGH END OF BALLOON WITH STENT ON IT, PUT IT IN BETWEEN MARKERS (2 OUTER IMAGE BANDS) COMPRESSED WITH THUMB AND INDEX ROLLED IT. USED UMBILICAL TAPE TO WRAP AROUND STENT AND FURTHER CRIMP DOWN. THE INDICATION THE PHYSICIAN WAS USING THE BALLOON FOR - C

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6581063 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.