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

Catalog Number	400SMTHXSFT2H08
Medical Device Problem Codes	Break (1069); Physical Resistance (2578); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the penumbra smart coil (smart coil) embolization coil was stretched in multiple locations along its length.The pusher assembly was bent in multiple locations along its length.There were several offset coil winds along the embolization coil length.There were no visible fractures of the pe fibers.Conclusions: evaluation of the returned device revealed that the embolization coil was damage along its length but remained intact with the pusher assembly with no pe fiber or coil filament fractures.This type of damage is likely the result of forceful attempts to maneuver the coil against resistance.The initial source of the resistance could not be determined.Further evaluation revealed that the pusher assembly was bent in multiple locations.This damage was likely incidental and may have occurred during packaging for return to penumbra facilities.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 in the ophthalmic artery using penumbra smart coils (smart coils).During the procedure, the physician successfully placed three smart coils using a non-penumbra microcatheter.While attempting to advance a fourth smart coil, the physician felt resistance and decided to remove the coil.Upon inspection after removal, the physician noticed that the coil filament was broken mid-coil.The coil was still intact but was not usable.Therefore, the procedure was completed using additional smart 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: 6541976
• Report Number: 3005168196-2017-00647
• Device Sequence Number: 18833678
• Product Code: HCG
• UDI-Device Identifier: 00814548016016
• UDI-Public: 00814548016016
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 04/04/2017

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: 12/14/2021
• Device Catalogue Number: 400SMTHXSFT2H08
• Device Lot Number: F73169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2017
• Initial Report FDA Received Date: 05/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR