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

Catalog Number	400SMTXSFT011H
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the penumbra smart coils (smart coils) pusher assembly.The pusher assembly was kinked approximately 44.5 cm from the proximal end.The embolization coil was intact with its pusher assembly.Conclusion: evaluation of the returned device revealed that the smart coil was able to be advanced through a demonstration microcatheter and out of the distal tip.The smart coil was advanced through a demonstration microcatheter; however, while advancing the smart coil through the demonstration microcatheter, resistance was encountered once the kink in the pusher assembly entered the hub of the microcatheter.The smart coil was advanced out the distal tip of the demonstration microcatheter with the resistance that occurred from the kink.The kink in the pusher assembly may have contributed to the resistance experienced during advancement.The microcatheter mentioned in the complaint was not returned for evaluation.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 to treat an anterior communicating artery (acom) aneurysm using penumbra smart coils (smart coils).During the procedure, the physician experienced resistance after advancing a smart coil half way through a non-penumbra microcatheter; therefore, it was removed.The procedure was completed using another smart coil and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was inadvertently missed on the initial mfr report and is being included on this follow-up #01 mfr report: report source.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6959784
• Report Number: 3005168196-2017-01842
• Device Sequence Number: 1222332
• Product Code: HCG
• UDI-Device Identifier: 00814548015170
• UDI-Public: 00814548015170
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 09/25/2017
• 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: Physician
• Device Expiration Date: 05/23/2022
• Device Catalogue Number: 400SMTXSFT011H
• Device Lot Number: F77294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2017
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/25/2017
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 10/18/2017
• Supplement Report FDA Received Date: 02/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Date Report Sent to FDA: 01/01/2005