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

Model Number	400SMTXSFT0406
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	09/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned smart coil revealed that the pusher assembly mid-joint was retracted within the introducer sheath friction lock.The smart coil was unable to advance from its returned position and the reported failure was confirmed.Forceful advancement against resistance likely contributed to the kinks near the pusher assembly mid-joint.If the pusher assembly mid-joint is retracted within the introducer sheath friction lock, resistance will likely be experienced while advancing the device and the device may not be advanced out of the introducer sheath.Further evaluation of the device revealed a kink near the distal tip of the introducer sheath.This damage was likely incidental to the complaint.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal carotid artery (ica) to the paraclinoid artery using penumbra smart coils (smart coils) and a non-penumbra microcatheter.During the procedure, one smart coil was successfully implanted into the target vessel.While attempting to advance the next smart coil, the physician experienced resistance and the coil would not advance past its initial position within its introducer sheath.Therefore, the smart coil was removed.The procedure was completed using another smart coil, a non-penumbra coil, and the same microcatheter.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12682902
• Report Number: 3005168196-2021-02357
• Device Sequence Number: 3856296
• Product Code: HCG
• UDI-Device Identifier: 00814548015385
• UDI-Public: 00814548015385
• 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
• Report Date (Section B): 10/22/2021
• 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: 01/10/2023
• Device Model Number: 400SMTXSFT0406
• Device Catalogue Number: 400SMTXSFT0406
• Device Lot Number: F81390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• 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: 09/27/2021
• Initial Report FDA Received Date: 10/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Date Report Sent to FDA: 01/01/2005