MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA COIL 400; HCG, KRD

Catalog Number	4006C0306
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report numbers: 3005168196-2019-01961; 3005168196-2019-01963.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the inferior mesenteric artery (ima) using penumbra coil 400s (pc400s), a pod4 and a penumbra coil 400 detachment handle (handle).During the procedure, while attempting to advance a pc400 into the target vessel using a lantern delivery microcatheter (lantern), the microcatheter kicked out of place.Therefore, the physician removed the pc400 and repositioned the lantern.While attempting to advance the same pc400 through the lantern, the physician experienced strong resistance and therefore, the pc400 was removed.It was reported that flushing the microcatheter did not resolve the resistance issue.Next, the physician advanced a pod4 and attempted to detach the coil using a handle; however, the pod4 failed to detach and, therefore, it was removed.It was also reported that the pod4 alignment zone was not divided in half.The procedure was completed using additional pc400s with the same handle and lantern.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9214988
• Report Number: 3005168196-2019-01962
• Device Sequence Number: 2524336
• Product Code: HCG
• UDI-Device Identifier: 00814548011837
• UDI-Public: 00814548011837
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2019
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/27/2026
• Device Catalogue Number: 4006C0306
• Device Lot Number: F83683
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 10/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Date Report Sent to FDA: 01/01/2005