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

Catalog Number	400SMTSTD1260
Medical Device Problem Codes	Detachment Of Device Component (1104); Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2017
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.The coil was implanted and the pusher assembly was disposed of.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right posterior communicating artery (pcomm) using penumbra smart coils (smart coils).It was noted that the patient's anatomy was not tortuous.During the procedure, the physician placed initial non-penumbra coils into the aneurysm using a non-penumbra microcatheter.While attempting to advance a new smart coil through the microcatheter with no resistance, the physician felt that the coil had unintentionally detach within the microcatheter.The smart coil was halfway outside of the microcatheter and into the aneurysm when it detached.Therefore, the physician used the smart coil pusher assembly to push the remaining amount of coil into the aneurysm.The procedure was then successfully completed using additional coils and the same microcatheter.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: 6988149
• Report Number: 3005168196-2017-01901
• Device Sequence Number: 102692
• Product Code: HCG
• UDI-Device Identifier: 00814548014449
• UDI-Public: 00814548014449
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/04/2017

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: 02/28/2022
• Device Catalogue Number: 400SMTSTD1260
• Device Lot Number: C00992
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2017
• Initial Report FDA Received Date: 10/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1