DELTAPAQ DFS101025-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00878528007999), received between Apr 12, 2017 and Apr 17, 2017 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Stretched” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2017Stretched; Stretched

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING AN ANEURYSM COILING PROCEDURE THE PHYSICIAN WAS UNABLE TO SIX PASS COILS THROUGH AN UNKNOWN MICROCATHETER. UPON TRYING AGAIN ALL THE COILS KINKED. THERE WERE NO DAMAGES NOTED ON THE COMPLAINT COILS PRIOR TO USE; HOWEVER, IT WAS REPORTED THAT THE COILS WERE STRETCHED WHEN THEY WERE REMOVED AND THEY WERE REMOVED ALONG WITH THE MICROCATHETER. IT IS UNKNOWN IF THE CATHETER WAS REMOVED FOR ALL THE SIX COIL AND THE TARGET SITE FOR THE COILING IS UNKNOWN. THE CATHETER USED WITH THE COILS WAS REPORTED TO BE KINKED. NO PRODUCTS WERE USED WITH THE CONCOMITANT DEVICES PRIOR TO THE ENCOUNTERED RESISTANCE. THE PROCEDURE WAS COMPLETED USING SAME LIKE PRODUCTS. THE HEALTHCARE PROFESSIONAL ALSO REPORTED THAT A NEUROSCOUT GUIDE WIRE DID NOT PASS THROUGH AN UNKNOWN PROWLER CATHETER. THERE WERE NO ADVERSE EVENTS AND THE PROCEDURE WAS NOT PROLONGED DUE TO THE REPORTED EVENT. THE COMPLAINT PRODUCTS ARE NOT AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6497145 ↗
• MalfunctionApr 17, 2017Stretched; Stretched

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING AN ANEURYSM COILING PROCEDURE THE PHYSICIAN WAS UNABLE TO SIX PASS COILS THROUGH AN UNKNOWN MICROCATHETER. UPON TRYING AGAIN ALL THE COILS KINKED. THERE WERE NO DAMAGES NOTED ON THE COMPLAINT COILS PRIOR TO USE; HOWEVER, IT WAS REPORTED THAT THE COILS WERE STRETCHED WHEN THEY WERE REMOVED AND THEY WERE REMOVED ALONG WITH THE MICROCATHETER. IT IS UNKNOWN IF THE CATHETER WAS REMOVED FOR ALL THE SIX COIL AND THE TARGET SITE FOR THE COILING IS UNKNOWN. THE CATHETER USED WITH THE COILS WAS REPORTED TO BE KINKED. NO PRODUCTS WERE USED WITH THE CONCOMITANT DEVICES PRIOR TO THE ENCOUNTERED RESISTANCE. THE PROCEDURE WAS COMPLETED USING SAME LIKE PRODUCTS. THE HEALTHCARE PROFESSIONAL ALSO REPORTED THAT A NEUROSCOUT GUIDE WIRE DID NOT PASS THROUGH AN UNKNOWN PROWLER CATHETER. THERE WERE NO ADVERSE EVENTS AND THE PROCEDURE WAS NOT PROLONGED DUE TO THE REPORTED EVENT. THE COMPLAINT PRODUCTS ARE NOT AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6497144 ↗
• MalfunctionApr 12, 2017Stretched; Stretched

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING AN ANEURYSM COILING PROCEDURE THE PHYSICIAN WAS UNABLE TO SIX PASS COILS THROUGH AN UNKNOWN MICROCATHETER. UPON TRYING AGAIN ALL THE COILS KINKED. THERE WERE NO DAMAGES NOTED ON THE COMPLAINT COILS PRIOR TO USE; HOWEVER, IT WAS REPORTED THAT THE COILS WERE STRETCHED WHEN THEY WERE REMOVED AND THEY WERE REMOVED ALONG WITH THE MICROCATHETER. IT IS UNKNOWN IF THE CATHETER WAS REMOVED FOR ALL THE SIX COIL AND THE TARGET SITE FOR THE COILING IS UNKNOWN. THE CATHETER USED WITH THE COILS WAS REPORTED TO BE KINKED. NO PRODUCTS WERE USED WITH THE CONCOMITANT DEVICES PRIOR TO THE ENCOUNTERED RESISTANCE. THE PROCEDURE WAS COMPLETED USING SAME LIKE PRODUCTS. THE HEALTHCARE PROFESSIONAL ALSO REPORTED THAT A NEUROSCOUT GUIDE WIRE DID NOT PASS THROUGH AN UNKNOWN PROWLER CATHETER. THERE WERE NO ADVERSE EVENTS AND THE PROCEDURE WAS NOT PROLONGED DUE TO THE REPORTED EVENT. THE COMPLAINT PRODUCTS ARE NOT AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6487091 ↗
• MalfunctionApr 12, 2017Stretched; Stretched

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING AN ANEURYSM COILING PROCEDURE THE PHYSICIAN WAS UNABLE TO SIX PASS COILS THROUGH AN UNKNOWN MICROCATHETER. UPON TRYING AGAIN ALL THE COILS KINKED. THERE WERE NO DAMAGES NOTED ON THE COMPLAINT COILS PRIOR TO USE; HOWEVER, IT WAS REPORTED THAT THE COILS WERE STRETCHED WHEN THEY WERE REMOVED AND THEY WERE REMOVED ALONG WITH THE MICROCATHETER. IT IS UNKNOWN IF THE CATHETER WAS REMOVED FOR ALL THE SIX COIL AND THE TARGET SITE FOR THE COILING IS UNKNOWN. THE CATHETER USED WITH THE COILS WAS REPORTED TO BE KINKED. NO PRODUCTS WERE USED WITH THE CONCOMITANT DEVICES PRIOR TO THE ENCOUNTERED RESISTANCE. THE PROCEDURE WAS COMPLETED USING SAME LIKE PRODUCTS. THE HEALTHCARE PROFESSIONAL ALSO REPORTED THAT A NEUROSCOUT GUIDE WIRE DID NOT PASS THROUGH AN UNKNOWN PROWLER CATHETER. THERE WERE NO ADVERSE EVENTS AND THE PROCEDURE WAS NOT PROLONGED DUE TO THE REPORTED EVENT. THE COMPLAINT PRODUCTS ARE NOT AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6487044 ↗