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

Catalog Number	400SMTSTD0510
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2017-01492.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the cerebral artery using penumbra smart coils and a penumbra smart coil detachment handle (handle).During the procedure, the physician deployed and detached initial smart coils into the target vessel using a non-penumbra microcatheter and the handle.The physician then deployed a new smart coil and attempted to detach the coil using the same handle; however, the smart coil did not detach even though the pet lock was separated.Therefore, the physician manually detached the smart coil by using forceps to pull back the detachment wire.The procedure was then completed using additional smart coils, the same handle and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was broken on the proximal end of the penumbra smart coil (smart coil) pusher assembly.The pusher assembly was kinked in multiple locations.The embolization coil was detached from its pusher assembly.Evaluation of the returned devices revealed that the smart coil¿s embolization coil was detached from its pusher assembly.Further evaluation of the returned device revealed that the pusher assembly was kinked in multiple locations.These kinks were likely incidental and may have occurred while packaging the device for return.Evaluation of the returned penumbra smart coil detachment handle (handle) revealed that the handle was nonfunctional.The handle was functionally tested on the handle fixture; however, while actuating the handle, the actuator inside the handle did not grip the pull wire on the handle fixture.After approximately 5 attempts, the handle began to grip the pull wire on the handle fixture and functioned as intended.Due to the initial unsuccessful attempts during functional analysis, the handle was deemed nonfunctional.The handle may have contributed to the detachment issue during the procedure.The non-penumbra microcatheter referred to in the complaint was not returned to penumbra for evaluation.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.Penumbra handles are visually inspected and 100% functionally tested during incoming inspection by quality.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6847125
• Report Number: 3005168196-2017-01491
• Device Sequence Number: 1141963
• Product Code: HCG
• UDI-Device Identifier: 00814548014630
• UDI-Public: 00814548014630
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 08/08/2017

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: 11/29/2021
• Device Catalogue Number: 400SMTSTD0510
• Device Lot Number: F72925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2017
• Initial Date Received by Manufacturer: 08/08/2017
• Supplement Date Received by Manufacturer: 03/23/2018
• Initial Report FDA Received Date: 09/06/2017
• Supplement Report FDA Received Date: 04/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR