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

Catalog Number	400SMTSFT0203
Medical Device Problem Codes	Kinked (1339); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/25/2016
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 number: 3005168196-2016-00220.Hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the basilar artery using smart coils.The physician successfully delivered the first smart coil (lot # f65143) in the aneurysm using another manufacturer's microcatheter and guide wire.Upon advancing a second smart coil in the aneurysm, the first smart coil became dislodged and approximately 3cm of the coil migrated into the right posterior cerebral artery (pca).The physician removed the second smart coil and used a snare device and another manufacturer's microcatheter in order to retrieve the proximal end of the first smart coil.After a few attempts to retrieve the smart coil, the snare device ruptured the vessel.Prior to any intervention by the physician, the bleeding stopped.The first smart coil was left in the pca and the procedure was completed using the second smart coil, that had previously been removed, and three additional smart coils.One smart coil (lot # f65207) was damaged by the technician on the back table and it was not used for the procedure.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5446986
• Report Number: 3005168196-2016-00219
• Device Sequence Number: 13520882
• Product Code: HCG
• UDI-Device Identifier: 00814548015118
• UDI-Public: 00814548015118
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K151572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/25/2016

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: 08/05/2020
• Device Catalogue Number: 400SMTSFT0203
• Device Lot Number: F65207
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2016
• Initial Report FDA Received Date: 02/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR