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

Catalog Number	4004C0408
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Blood Loss (2597)
Date of Event	03/03/2015
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.The coil 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 the second pc400 in the aneurysm, perforation of the aneurysm sac was observed.The bleeding lasted approximately five minutes as the perforation was sealed by implanting a third pc400.No further treatment was required for the bleeding and post-procedure neurological examination was normal.On (b)(6) 2016, this adverse event was adjudicated to have an uncertain relationship to the pc400 system and a possible relationship to both the angiographic procedure and the aneurysm disease state.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5796867
• Report Number: 3005168196-2016-01008
• Device Sequence Number: 16287889
• Product Code: HCG
• UDI-Device Identifier: 00814548010830
• UDI-Public: 00814548010830
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 06/17/2016

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: 12/31/2021
• Device Catalogue Number: 4004C0408
• Device Lot Number: F39978
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2016
• Initial Report FDA Received Date: 07/14/2016
• 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: Other
• Patient Age: 73 YR