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

Model Number	400SMTSFT4H10
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	02/09/2021
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 internal carotid-posterior communicating artery (icpc) using penumbra smart coils (smart coils) and a non-penumbra microcatheter.It was reported the patient anatomy was mildly tortuous, calcified and narrowed.During the procedure, the physician implanted a smart coil in the target location.Subsequently, after advancing the next smart coil a few centimeters in the introducer sheath, the smart coil was stuck.The physician made another attempt but was unable to advance the smart coil.Therefore, the smart coil was removed.The procedure was completed using three non-penumbra coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned smart coil revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If this occurs, resistance will likely be experienced while advancing the device and the device may not be advanced out of the introducer sheath.Forceful advancement against this resistance may have contributed to the pusher assembly kink which was observed near the mid-joint.During functional testing, the pusher assembly mid-joint was advanced through the introducer sheath friction lock with resistance then the smart coil was able to advance through its introducer sheath without an issue.Further evaluation of the device revealed addition pusher assembly kinks.This damage was likely incidental to the complaint and may have occurred during packaging for the return.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: 11581654
• Report Number: 3005168196-2021-00602
• Device Sequence Number: 14498807
• Product Code: HCG
• UDI-Device Identifier: 00814548017051
• UDI-Public: 00814548017051
• 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): 03/01/2021
• 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: 07/24/2022
• Device Model Number: 400SMTSFT4H10
• Device Catalogue Number: 400SMTSFT4H10
• Device Lot Number: F78348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 03/29/2021
• Supplement Report FDA Received Date: 04/26/2021
• 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