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

Catalog Number	4004C0830
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/30/2015
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: 3005168196-2016-00127, 3005168196-2016-00129, 3005168196-2016-00130.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the inferior mesenteric artery using penumbra coil 400 coils (pc400 coils) and penumbra coil detachment handles (handles).During the procedure, the physician successfully deployed and detached three pc400 coils into the aneurysmatic sac.A fourth pc400 coil (lot # f43753) was then deployed into the patient; however, the physician was unable to detach the coil using the handle (lot # f42954) even after manually pulling back on the pc400 coil pusher assembly.The pc400 coil was removed from the patient and a fifth pc400 coil (lot # f63337) was deployed.However, the physician was unable to detach this fifth coil using a new handle (lot # f62622) and removed the coil from the patient.The procedure was completed using another manufacturer's coils.It was reported that the patient's anatomy was tortuous.There was a tight corner of about 150 degrees at the beginning of the superior mesenteric artery through another manufacturer's microcatheter and after that, there was a long and tortuous path through the riolano circulation to the aneurysmatic sac in the inferior mesenteric artery.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report:3005168196-2016-00128.This report is associated with mfr report numbers: 3005168196-2016-00127.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5414136
• Report Number: 3005168196-2016-00128
• Device Sequence Number: 508444
• Product Code: HCG
• UDI-Device Identifier: 00814548010939
• UDI-Public: 00814548010939
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• 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: Other
• Type of Report: Followup
• Report Date (Section B): 01/07/2016
• 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: Physician
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 4004C0830
• Device Lot Number: F63337
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 02/05/2016
• Supplement Report FDA Received Date: 12/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Date Report Sent to FDA: 01/01/2005