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

Catalog Number	400SMTXSFT3H08
Medical Device Problem Codes	Physical Resistance (2578); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pusher assembly was kinked approximately 133.0 and 138.0 cm from the proximal end.The embolization coil was intact with the pusher assembly.Conclusions: evaluation of the returned device revealed the pusher assembly was kinked near the proximal end of the introducer sheath.This damage likely occurred due to forceful advancement against resistance.During functional testing, the pusher assembly kinks caused resistance when advancing the smart coil through its introducer sheath and demonstration microcatheter; however, the smart coil was eventually able to advance completely through the microcatheter.The root cause of the initial resistance experienced during the procedure 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 in the left and right vertebral artery (va) using penumbra smart coils (smart coils).During the procedure, the physician deployed and detached six smart coils in the target vessel using a non-penumbra microcatheter.While attempting to advance and new smart coil through the microcatheter, the physician experienced resistance when passing over the hub of the microcatheter and subsequently, the smart coil became stuck; therefore, it was removed.The procedure was completed using two 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: 7317840
• Report Number: 3005168196-2018-00461
• Device Sequence Number: 119342
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/07/2018

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: 02/21/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2018
• Initial Report FDA Received Date: 03/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR