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

Catalog Number	400SMTXSFT0103
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	02/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2019-00567.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior choroidal artery using penumbra smart coils (smart coils).During the procedure, the physician experienced resistance and was not able to advance the smart coil into the non-penumbra microcatheter.Therefore, the physician removed the smart coil and attempted to advance a new smart coil; however, the same issue occurred.It was reported that the physician noticed a space between the tip of the introducer sheath of the smart coil and the hub of the microcatheter.Subsequently, the procedure was completed using a new smart coil with the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up 3005168196-2019-00566 mfr report.This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 94.0, 130.5 and 133.5 cm from the proximal end.The pusher assembly was advanced within the introducer sheath.The embolization coil had offset coil winds and was intact with the pusher assembly distal detachment tip (ddt).Conclusions: evaluation of the returned smart coil revealed proximal offset coil winds.If the introducer sheath is not aligned properly within the hub of its parent catheter, the embolization coil may take shape within the hub and resistance may be experienced during advancement.If the device is forcefully advanced against resistance, damage such as offset coil winds may occur.During functional testing, the smart coil became stuck in the hub of a demonstration microcatheter.Further evaluation revealed pusher assembly kinks.The kinks likely occurred when the device was advanced against resistance.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.This report is associated with mfr report number: 3005168196-2019-00567.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8454190
• Report Number: 3005168196-2019-00566
• Device Sequence Number: 16891381
• Product Code: HCG
• UDI-Device Identifier: 00814548015194
• UDI-Public: 00814548015194
• Combination Product (Y/N): Y
• Initial Reporter Country: LE
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/26/2019
• 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: 12/18/2021
• Device Catalogue Number: 400SMTXSFT0103
• Device Lot Number: F73219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 06/04/2019; 06/04/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 06/28/2019; 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Date Report Sent to FDA: 01/01/2005