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

Model Number	400SMTHXSFT0203
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	05/30/2020
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the basilar artery using penumbra smart coils (smart coils), non-penumbra coils, and a non-penumbra microcatheter.During the procedure, the microcatheter was used to implant two other coils and two smart coils into the target vessel.While advancing the next smart coil, it became stuck just past the hub of the microcatheter.Therefore, the smart coil was removed.The procedure was completed using four other coils and 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 #01 mfr report.Section h.Box 3.Device returned to manufacturer? 2.Section h.Box 6 device code 1 & device code 2.Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked at approximately 77.0 cm from the proximal end.The embolization coil was intact with the pusher assembly and had offset coil wind.Conclusions: evaluation of the returned smart coil revealed offset coil winds on its embolization coil.If the introducer sheath is not properly aligned with the hub of the microcatheter prior to advancement, resistance may be encountered and damage such as offset coil winds may occur.During functional testing, the returned smart coil was able to advance through its introducer sheath and a demonstration microcatheter without issue.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.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10195173
• Report Number: 3005168196-2020-00815
• Device Sequence Number: 16760305
• Product Code: HCG
• UDI-Device Identifier: 00814548015705
• UDI-Public: 00814548015705
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 06/02/2020
• 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: 01/29/2023
• Device Model Number: 400SMTHXSFT0203
• Device Catalogue Number: 400SMTHXSFT0203
• Device Lot Number: F81653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/02/2020
• Supplement Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 06/25/2020
• Supplement Report FDA Received Date: 07/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005