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

Catalog Number	400SMTXSFT3H08
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pusher assembly was kinked approximately 120.0 and 130.0 cm from the proximal end.The embolization coil was intact with the pusher assembly, was compressed, and had offset coil winds throughout its length.Conclusions: evaluation of the returned device revealed the pusher assembly was kinked and the embolization coil was compressed and offset.This damage likely occurred due to forceful advancement of the smart coil against resistance.During functional testing, the smart coil was advanced through its introducer sheath and a demonstration microcatheter without issue.Therefore, the root cause of the initial reported resistance could not be determined.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 dural arteriovenous fistula (d-avf) using penumbra smart coils (smart coils).During the procedure, the physician deployed and detached two smart coils in the target vessel using a non-penumbra microcatheter.While attempting to advance a new smart coil through the microcatheter, the physician experienced resistance and subsequently, the smart coil became stuck in its introducer sheath and would not advance further through the microcatheter; therefore, it was removed.The procedure was 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: 7149405
• Report Number: 3005168196-2017-02300
• Device Sequence Number: 1109082
• Product Code: HCG
• UDI-Device Identifier: 00814548017129
• UDI-Public: 00814548017129
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/29/2017

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: 06/13/2022
• Device Catalogue Number: 400SMTXSFT3H08
• Device Lot Number: F77666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 12/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR