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

Catalog Number	400SMTXSFT2H04
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	07/09/2018
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 33.5, 35.0, 44.0, and 45.5 cm and bent approximately 5.5, 12.0, 58.0, 79.0, 118.5, and 127.0 cm from the proximal end of the pusher assembly.The embolization coil was stretched but intact with the pusher assembly.Dried coagulated blood was found along the length of the embolization coil and pusher assembly.Conclusions: evaluation of the returned smart coil revealed a stretched embolization coil.Blood was found coagulated on the embolization coil and pusher assembly.If blood coagulated on the device, it may have contributed to resistance and the reported inability to advance the device into the microcatheter.If the device is forcefully advanced and retracted while experiencing resistance, damage such as stretching of the embolization coil may occur.Further evaluation revealed kinks and bends on the pusher assembly.If the device is advanced while experiencing resistance, damage such as kinks and bends may occur.Based on the return condition, some of the kinks and bends are likely incidental to the complaint and may have occurred during packaging for return to penumbra.Penumbra coils are visually 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 using penumbra smart coils (smart coils).During the procedure, the physician successfully placed multiple smart coils using a non-penumbra microcatheter.The physician experienced resistance and then was unable to advance a smart coil through the hub of the microcatheter and, therefore, the smart coil was removed.The procedure was completed using a new smart coil 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: 7754303
• Report Number: 3005168196-2018-01525
• Device Sequence Number: 13872812
• Product Code: HCG
• UDI-Device Identifier: 00814548015323
• UDI-Public: 00814548015323
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 07/09/2018
• 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: 11/30/2022
• Device Catalogue Number: 400SMTXSFT2H04
• Device Lot Number: F80833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• 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: 07/09/2018
• Initial Report FDA Received Date: 08/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Date Report Sent to FDA: 01/01/2005