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

Catalog Number	400SMTXSFT0202
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/28/2016
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: 3005168196-2016-00732.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils).During the procedure, while attempting to advance a smart coil through another manufacturer's microcatheter, the physician experienced friction and the smart coil was unable to advance.Therefore, the smart coil was removed and the microcatheter was replaced with another manufacturer's microcatheter.The physician then deployed a new smart coil into the aneurysm but mistakenly used the wrong ruby coil detachment handle (handle) to detach the coil.Consequently, the coil was unable to detach and the smart coil pusher assembly became stuck in the handle and could not be removed.Therefore, the procedure was completed using another manufacturer's coil.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5695111
• Report Number: 3005168196-2016-00731
• Device Sequence Number: 103665
• Product Code: HCG
• UDI-Device Identifier: 00814548015262
• UDI-Public: 00814548015262
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• 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): 05/03/2016

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: 02/24/2021
• Device Catalogue Number: 400SMTXSFT0202
• Device Lot Number: F68114
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2016
• Initial Report FDA Received Date: 06/02/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR