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

Catalog Number	400SMTHXSFT0101
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 139.0 cm from the proximal end.The pusher assembly mid-joint was positioned proximal to the introducer sheath friction lock.The embolization coil was undamaged and intact with the pusher assembly distal detachment tip ddt.Conclusions: evaluation of the returned smart coil revealed the pusher assembly mid-joint was positioned proximal to the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement of the smart coil within its introducer sheath.Further evaluation revealed a pusher assembly kink near the mid-joint.This damage was likely a result of forceful advancement against resistance.During functional testing, the smart coil was able to advance out of its introducer sheath with resistance while advancing the pusher assembly mid-joint through the introducer sheath friction lock.However, while attempting to advance the smart coil through the hub of a demonstration microcatheter, resistance was experienced due to the pusher assembly kink and the coil could not advance any further.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 posterior communicating artery (pcom) using penumbra smart coils (smart coils).During the procedure, the physician experienced resistance and reported that the smart coil would not advance out of its introducer sheath into the non-penumbra microcatheter.The smart coil was therefore removed and was no longer used in the procedure.The procedure was completed using a new smart coil.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: 9172670
• Report Number: 3005168196-2019-01912
• Device Sequence Number: 14087621
• Product Code: HCG
• UDI-Device Identifier: 00814548015590
• UDI-Public: 00814548015590
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/13/2019
• Report Date (Section F): 01/01/2005

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: Health Professional
• Device Expiration Date: 01/14/2024
• Device Catalogue Number: 400SMTHXSFT0101
• Device Lot Number: F87947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 10/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Date Report Sent to FDA: 01/01/2005