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

Catalog Number	400SMTXSFT0101
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right anterior cerebral artery (aca) using penumbra smart coils (smart coils).During the procedure, the physician was unable to advance a smart coil out its introducer sheath and into the hub of a non-penumbra microcatheter.Therefore, the smart coil was removed and the procedure was successfully completed using a new smart coil and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the penumbra smart coil (smart coil) pusher assembly had multiple kinks along its length.The embolization coils had offset coils winds on its proximal end.Evaluation of the returned smart coil revealed offset coil winds on the proximal end of the embolization coil.If the introducer sheath is not properly aligned in the hub prior to advancing the coil, offset coil winds may result.These offset coil winds may contribute to further resistance experienced when advancing the coil.Further evaluation revealed multiple kinks along the length of the pusher assembly.This damage is likely a result of winding the smart coil tightly for return to penumbra.During functional testing, the embolization coil was able to be advanced pass the hub of the returned non-penumbra microcatheter without issue.Resistance increased as the coil was advanced further through the microcatheter.This resistance was likely due to the multiple kinks on the pusher assembly.Since the embolization coil was able to be advanced pass the hub and out the distal tip of the microcatheter, the root cause of the inability to advance the embolization coil into the microcatheter could not be determined.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.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #02 mfr report.1.Section g.Box 3.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: 7009866
• Report Number: 3005168196-2017-01945
• Device Sequence Number: 489092
• Product Code: HCG
• UDI-Device Identifier: 00814548015163
• UDI-Public: 00814548015163
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 10/10/2017
• 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: 10/13/2021
• Device Catalogue Number: 400SMTXSFT0101
• Device Lot Number: F72046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2017
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/10/2017
• Supplement Date Received by Manufacturer: 12/08/2017; 01/14/2005
• Initial Report FDA Received Date: 11/08/2017
• Supplement Report FDA Received Date: 01/05/2018; 11/25/2019
• 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