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

Catalog Number	400SMTSTD0510
Medical Device Problem Codes	Detachment Of Device Component (1104); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was pulled off the pusher assembly hypotube and pull wire.The pusher assembly was kinked in multiple locations.The embolization coil was detached from the pusher assembly.Conclusions: evaluation of the returned device revealed the pet lock was pulled off the proximal end of the pusher assembly.This damage may have occurred due to forceful handling of the smart coil during retraction.If the pet lock is pulled off the pusher assembly, it may allow the pull wire to retract out of the distal detachment tip, which would allow the embolization coil to detach.Further evaluation revealed the pusher assembly was kinked in multiple locations.This damage was likely incidental and may have occurred during packaging for return to penumbra.The non-penumbra microcatheter mentioned in the complaint was not returned for evaluation.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a cerebral aneurysm using penumbra smart coils (smart coils).During the procedure, after advancing a smart coil out of a non-penumbra microcatheter, the physician felt friction and decided to withdraw the smart coil.However, while retracting the smart coil into the microcatheter, the physician felt friction and subsequently, the smart coil unintentionally detached from its pusher assembly inside the microcatheter.Therefore, the physician removed the microcatheter containing the detached coil and the procedure was then completed using additional smart coils and a new microcatheter without further issues.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: 6684941
• Report Number: 3005168196-2017-01068
• Device Sequence Number: 72350
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/05/2017

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: 10/02/2021
• Device Catalogue Number: 400SMTSTD0510
• Device Lot Number: F71886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2017
• Initial Report FDA Received Date: 07/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR