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

Catalog Number	400SMTSTD0615
Medical Device Problem Codes	Kinked (1339); Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the penumbra smart coil (smart coil) pusher assembly was kinked approximately 132.0, 133.0, and 135.0 cm from the proximal end.The embolization coil was intact with the pusher assembly and had offset coil windings in multiple locations.The pet heat shrink material on the introducer sheath friction lock was compressed.Conclusions: evaluation of the returned device revealed the smart coil could not be advanced through its introducer sheath due to kinks in the pusher assembly, and the introducer sheath friction lock was compressed.The pusher assembly kinks and compression of the friction lock likely occurred due to forceful handling of the smart coil during insertion.Further evaluation revealed the embolization coil windings were offset in multiple locations.If the introducer sheath is not properly seated in the hub of the microcatheter when the smart coil is being initially inserted, the embolization coil may begin to take shape in the hub, and resistance may be encountered.Manipulation of the smart coil while it was taking shape inside the hub may have caused the coil windings to become offset, which would have further contributed to the resistance experienced by the physician.The non-penumbra sheath, catheter, and microcatheter mentioned in the complaint were 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 cerebral artery using penumbra smart coils (smart coils).During the procedure, the physician advanced another manufacturer¿s guiding sheath, catheter and microcatheter in the target vessel.The physician then connected a smart coil introducer sheath to the hub of the microcatheter and attempted to advance the smart coil; however, resistance was experienced and the smart coil would not advance into the microcatheter.Therefore, the physician removed the smart coil introducer sheath from the hub of the microcatheter and attempted to advance the smart coil out of its introducer sheath.However, resistance was experienced while advancing the smart coil outside of the introducer sheath.Next, the physician re-connected the smart coil introducer sheath to the hub of the microcatheter then re-attempted to advance the smart coil; however, resistance was encountered again and subsequently the smart coil pusher assembly became kinked.Therefore, it was removed and the procedure was completed using another manufacturer¿s coils and an additional smart coil.It should be noted that the physician did not use a rotating hemostasis valve (rhv) throughout this procedure.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: 6408242
• Report Number: 3005168196-2017-00395
• Device Sequence Number: 10961931
• Product Code: HCG
• UDI-Device Identifier: 00814548014661
• UDI-Public: 00814548014661
• 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): 02/16/2017

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: 07/26/2021
• Device Catalogue Number: 400SMTSTD0615
• Device Lot Number: F70834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2017
• Initial Report FDA Received Date: 03/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR