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

Catalog Number	400SMTSFT0610
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/13/2017
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.This report is associated with mfr report numbers: 3005168196-2017-02185, 3005168196-2017-02186.The device was implanted in the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a cavernous carotid aneurysm using penumbra smart coils (smart coils) and a penumbra smart coil detachment handle (handle).During the procedure, the physician advanced and smart coil in the target vessel and attempted to detach it using the handle.It was reported that the pet lock on the pusher assembly was separated; however, while attempting to remove the coil pusher assembly, the physician noticed that the coil was not detached.At this time, the smart coil was already pulled out of the aneurysm and therefore, was re-advanced into the aneurysm without issue.The physician then pinned the smart coil pusher assembly then pulled the pull wire and manually detached and placed the smart coil in the aneurysm.It was also reported that the same issue occurred with another smart coil using the same handle; therefore, the smart coil was manually detached as well.The procedure was completed with a total seven smart coils and the same handle.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: 7106424
• Report Number: 3005168196-2017-02184
• Device Sequence Number: 782119
• Product Code: HCG
• UDI-Device Identifier: 00814548014968
• UDI-Public: 00814548014968
• 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
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/13/2017

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: 02/23/2022
• Device Catalogue Number: 400SMTSFT0610
• Device Lot Number: F74603
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 12/11/2017
• 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