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

Catalog Number	400SMTSTD1860
Medical Device Problem Code	Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/16/2018
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: 3005168196-2018-00554.The device was implanted in the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal carotid artery (ica) using penumbra smart coils (smart coils).During the procedure, the physician successfully placed coils in the target location using a non-penumbra microcatheter.It was reported that the physician experienced resistance while advancing a smart coil into the target location; however, the smart coil was able to be successfully deployed and detached.The physician then experienced resistance and was unable to advance another smart coil through the microcatheter.Consequently, the smart coil pusher assembly became kinked in multiple locations, causing the smart coil to unintentionally detach while partially within the aneurysm and partially outside the aneurysm.The loop of the detached smart coil that was outside of the aneurysm was pinned to the vessel wall by a non-penumbra stent, and therefore no attempts were made to remove the detached smart coil from the patient.The procedure ended at this point.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: 7338542
• Report Number: 3005168196-2018-00555
• Device Sequence Number: 1227945
• Product Code: HCG
• UDI-Device Identifier: 00814548014340
• UDI-Public: 00814548014340
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/16/2018

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: 05/01/2022
• Device Catalogue Number: 400SMTSTD1860
• Device Lot Number: F76891
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2018
• Initial Report FDA Received Date: 03/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1