DELTAPAQ DFS100925-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00878528007968), received between Nov 16, 2018 and Mar 25, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2019Stretched; Material Twisted/Bent; Stretched; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION OF A SHORT NECK SPLENIC ARTERY ANEURYSM, THE 9MM X 25CM DELTAPAQ 10 STRETCH RESISTANT COIL (DFS10092520 / S10053) WAS CHOSEN AFTER PREVIOUS COILS WERE ADVANCED AND PLACED THROUGH THE PROWLER SELECT PLUS MICROCATHETER. THE DELTAPAQ 10 STRETCH RESISTANCE COIL BECAME IMPEDED IN THE DISTAL THIRD OF THE MICROCATHETER AND COULD NOT BE ADVANCED TO THE TARGET LESION. THE COIL WAS REMOVED TO BE RETURNED FOR EVALUATION AND ANALYSIS. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE OR ADVERSE EVENT ASSOCIATED WITH THE EVENT. THE 9MM X 25CM DELTAPAQ 10 STRETCH RESISTANT COIL WAS RETURNED FOR EVALUATION WHICH REVEALED THAT THE EMBOLIC COIL WAS KINKED AND STRETCHED. BASED ON THE PRODUCT ANALYSIS COMPLETED ON 3/19/2019, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8450154 ↗
• MalfunctionNov 16, 2018Material Deformation; Material Deformation

  AS REPORTED BY THE (B)(6), DURING USE OF A 9MM X 25CM DELTAPAQ ((B)(4) THERMO-MECHANICAL COIL, COMPRESSION OF THE ¿SPRING¿ WAS NOTED, MAKING IT IMPOSSIBLE TO ¿PROGRESS¿. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. IT WAS REPORTED THAT THE INFORMATION PROVIDED FOR THIS COMPLAINT WAS ALL OF THE DETAILS THAT WERE KNOWN/AVAILABLE REGARDING THIS EVENT. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8080680 ↗