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

Catalog Number	4006C0204
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/24/2016
Type of Reportable Event	Serious Injury
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: 3005168196-2016-00932, 3005168196-2016-00933, 3005168196-2016-00934.The device remains implanted in the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coils 400 (pc400).During the procedure, after delivering four pc400 coils in the target vessel, it was noticed that a pc400 loop was prolapsing in the anterior communicating artery (acom).No flow or thromboembolic problems were observed; however, the protruding pc400 loop was secured using a stent and dual antiplatelet therapy (dapt).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: 6498920
• Report Number: 3005168196-2016-00935
• Device Sequence Number: 16303853
• Product Code: HCG
• UDI-Device Identifier: 00814548011783
• UDI-Public: 00814548011783
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 4006C0204
• Device Lot Number: F63831
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2016
• Initial Report FDA Received Date: 04/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR