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

Catalog Number	400SMTSTD1030
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pusher assembly was kinked approximately 33.0, 75.0, and 80.0 cm from the proximal end.The embolization coil instances of offset coil winds near its proximal end.Conclusions: evaluation of the returned smart coil revealed multiple kinks and offset coil winds.If the embolization coil is advanced prior to the introducer sheath being properly aligned in the hub of the microcatheter, resistance will likely be experiences.Advancing the smart coil against this resistance will likely cause offset coil winds? these offset coil winds likely contributed to the inability to advance the embolization coil within its sheath.Further evaluation revealed multiple kinks on the pusher assembly.This damage was likely cause by forcefully advancing against the previously mentioned resistance.A portion of these kinks may have been incidental and occurred during packaging for return to penumbra.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 right sigmoid sinus using penumbra smart coils (smart coils).During the procedure, while attempting to advance a smart coil through a non-penumbra microcatheter, the distal tip of the smart coil curled inside the hub of the microcatheter and would not advance into the microcatheter; therefore, it was removed.The procedure was completed using additional smart coils, other 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: 7567650
• Report Number: 3005168196-2018-01103
• Device Sequence Number: 19348633
• Product Code: HCG
• UDI-Device Identifier: 00814548014395
• UDI-Public: 00814548014395
• 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): 05/07/2018

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: 03/29/2022
• Device Catalogue Number: 400SMTSTD1030
• Device Lot Number: F75294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 06/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR