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

Model Number	400SMTSTD1045
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned smart coil could not confirm the reported complaint that the device was unable to advance from its starting position as it was also reported that the smart coil was later able to be advanced on the back table post-procedure.The root cause of the reported complaint could not be determined.During functional testing, the smart coil was advanced through its introducer sheath without an issue.Further evaluation also confirmed kinks on the pusher assembly.This damage was reported to have occurred post-procedure while handling the device and is therefore incidental to the initial complaint.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 carotid-posterior communicating artery (ic-pc) using penumbra smart coils (smart coils) and a non-penumbra microcatheter.During the procedure, three smart coils were implanted into the target vessel followed by one non-penumbra coil, and one smart coil.The next smart coil was unable to move past its initial position within its introducer sheath.Therefore, the smart coil was removed.While manipulating the smart coil on the back table post-procedure, the physician was able to advance the coil before kinking the pusher assembly.The procedure was completed using four additional smart coils, fifty-one non-penumbra coils, 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: 12566449
• Report Number: 3005168196-2021-02187
• Device Sequence Number: 19186245
• Product Code: HCG
• UDI-Device Identifier: 00814548014401
• UDI-Public: 00814548014401
• 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): 10/02/2021
• 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: 08/20/2022
• Device Model Number: 400SMTSTD1045
• Device Catalogue Number: 400SMTSTD1045
• Device Lot Number: F78753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• 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: 09/07/2021
• Initial Report FDA Received Date: 10/02/2021
• 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