CP Stent™ 614376Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046964899560), received between Jun 27, 2017 and Jun 27, 2017 — classified as 2 malfunctions.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2017Detachment Of Device Component

  AS PER THE REPORT FROM DISTRIBUTOR - "AS PHYSICIAN WAS PREPARING TO INFLATE THE INNER BALLOON. IT WAS DETERMINED THAT THE STENT HAD PARTIALLY SLID OFF THE BALLOON. PHYSICIAN REALIZED THE ENTIRE SYSTEM HAD TO BE REMOVED, THE STENT CAME COMPLETELY OFF THE BALLOON AND WAS LEFT IN THE DESCENDING AORTA. PHYSICIAN QUICKLY MOVED BACK IN WITH THE SHEATH AND WAS ABLE TO GET THE TIP OF THE SHEATH TO PARTIALLY INSERT INTO THE END OF THE STENT, AS THE END FLARED A BIT. PHYSICIAN THEN CAME IN WITH A SNARE AND GRABBED THE SHEATH FROM THE PROXIMAL END, AND THEN MOVED THE STENT FORWARD TO THE APPROXIMATE TARGET AREA. NEXT, PHYSICIAN INSERTED A 22MM BALLOON AND SUCCESSFULLY EXPANDED THE CP STENT WITH PERFECT PLACEMENT. AFTER THIS STEP WAS COMPLETED IT WAS REALIZED THAT ON BOTH THIS CASE AND THE PREVIOUS CASE, PHYSICIAN DID NOT INSERT THE BLUE INSERTION SLEEVE THROUGH THE VALVE OF THE SHEATH. THE 14F HEMOSTASIS TOOL PROVIDED BY NUMED WAS USED. PHYSICIAN DID NOT ATTEMPT TO PULL THE STENT BACK THROUGH THE HEMOSTASIS VALVE AT ANY TIME." CLARIFICATION FROM BIS SPECIALIST - SENT ON 6/22/2017 - "THE PHYSICIAN DID USE THE TOOLS PROVIDED BY NUMED, HOWEVER, THE PHYSICIAN DID NOT INSERT THE INSERTION SLEEVE F

  Patient problems: No Information

  MAUDE report 6669202 ↗
• MalfunctionJun 27, 2017Device Slipped; Improper or Incorrect Procedure or Method

  AS PER THE REPORT FROM DISTRIBUTOR - "AFTER UNSHEATHING THE STENT IN THE DESIRED LOCATION AND THE INNER BALLOON WAS INFLATED, IT WAS DETERMINED THAT THE STENT HAD PARTIALLY SLID OFF THE BALLOON. THE DOCTOR WAS ABLE TO PARTIALLY INFLATE THE OUTER BALLOON, DEFLATE, MOVE, AND PROPERLY EXPAND THE REMAINDER OF THE STENT. THE END RESULT WAS PERFECT PLACEMENT AND THE GRADIENT WAS NO LONGER PRESENT. SALINE WAS USED DURING PREP. THE 14F HEMOSTASIS TOOL PROVIDED BY NUMED WAS USED. PHYSICIAN DID NOT ATTEMPT TO PULL THE STENT BACK THROUGH THE NEOSTASIS VALVE AT ANY TIME." CLARIFICATION FROM BIS SPECIALIST - SENT ON 6/22/2017 - "THE PHYSICIAN DID USE THE TOOLS PROVIDED BY NUMED, HOWEVER, THE PHYSICIAN DID NOT INSERT THE INSERTION SLEEVE FAR ENOUGH."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6669198 ↗