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

Model Number	400SMTHXSFT0208
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned smart coil could not confirm the reported complaint.Evaluation revealed that the embolization coil had offset coil winds; this indicates that the smart coil was likely advanced from its starting position.If the smart coil is forcefully advanced against resistance, damage such as this may occur.Based on the reported complaint, the root cause of resistance could not be determined.Further evaluation revealed the pet lock was separated on the proximal end of the pusher assembly, the pusher assembly had bends and kinks, and the pusher assembly mid-joint was retracted through the introducer sheath friction lock.This damage was likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal thoracic artery using penumbra smart coils (smart coils) and a non-penumbra microcatheter.During the procedure, the physician placed two smart coils into the target location using the microcatheter.While advancing the next smart coil within its introducer sheath, the physician experienced resistance.Subsequently, the smart coil would not advance at all from its initial position within its introducer sheath.Therefore, the smart coil was removed.The procedure was completed using ten smart coils and twenty non-penumbra coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Conclusions code (4316):the investigation findings do not lead to a clear conclusion about the root cause of the reported resistance.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: 1.Section g.Box 4.Date received by manufacturer 2.Section h.Box 6.Result codes 1,2 & 3 3.Section h.Box 6.Conclusion code h3 other text : placeholder.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 12741019
• Report Number: 3005168196-2021-02452
• Device Sequence Number: 4126779
• Product Code: HCG
• UDI-Device Identifier: 00814548015996
• UDI-Public: 00814548015996
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2022
• 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: 04/11/2026
• Device Model Number: 400SMTHXSFT0208
• Device Catalogue Number: 400SMTHXSFT0208
• Device Lot Number: F105319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2021
• Is the Reporter a Health Professional?: Yes
• 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: 10/05/2021
• Supplement Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/01/2005