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

Model Number	400SMTHXSFT2H06
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	07/15/2021
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 middle cerebral artery (mca) using penumbra smart coils (smart coils), a non-penumbra catheter, and a guidewire.It should be noted that the patient's anatomy was tortuous, calcified, and narrowed.During the procedure, the physician successfully implanted three smart coils and four non-penumbra coils.When the next smart coil was partially advanced into the hub, resistance was encountered at the distal tip of the introducer sheath and the coil became stuck.Therefore, the smart coil was removed.The procedure was completed using another smart coil and eight other coils with the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned smart coil could not confirm the reported complaint.Further evaluation revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement.Further evaluation also revealed a pusher assembly kink.This damage was incidental to the reported complaint and may have occurred while packaging the device for return.During functional testing, the pusher assembly mid-joint was advanced through the introducer sheath friction lock with resistance.After the pusher assembly mid-joint was advanced through the introducer sheath friction lock, additional resistance was encountered due to the kink in the pusher assembly while advancing the pusher assembly completely through the introducer sheath and a demonstration microcatheter.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.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of the resistance encountered by the smart coil at the distal tip of the introducer sheath and becoming stuck.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12343204
• Report Number: 3005168196-2021-01845
• Device Sequence Number: 11746951
• Product Code: HCG
• UDI-Device Identifier: 00814548015767
• UDI-Public: 00814548015767
• 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): 09/08/2021
• 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: 02/24/2026
• Device Model Number: 400SMTHXSFT2H06
• Device Catalogue Number: 400SMTHXSFT2H06
• Device Lot Number: F104132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/25/2021
• Supplement Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 08/19/2021
• Supplement Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Date Report Sent to FDA: 01/01/2005