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

Model Number	400SMTXSFT2H06
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Difficult or Delayed Separation (4044); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned smart coil confirmed that the embolization coil was detached from the pusher assembly.Evaluation revealed that the pet lock was separated, and the pull wire was retracted from the pusher assembly ddt.The separated pet lock was likely due to the coil detachment attempted during the procedure.If the pet lock is separated, the pull wire will retract from the pusher assembly ddt, the embolization coil will detach from the pusher assembly.The detached embolization coil was not returned for evaluation.Further evaluation of the device revealed kinks on pusher assembly.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 m1 segment of the middle cerebral artery (mca) using penumbra smart coils (smart coil), a penumbra smart coil detachment handle (handle), and a non-penumbra microcatheter.During the procedure, the physician advanced the smart coil into the aneurysm using the microcatheter and attempted to detach it using the handle; however, the smart coil failed to detach.The physician then decided to remove the smart coil.Upon retraction, the physician experienced resistance and noticed that the smart coil had unintentionally detached inside the microcatheter.Therefore, the physician used another smart coil to push the detached smart coil back into the aneurysm and implanted both smart coils successfully.The procedure was completed using additional smart coils and the same handle.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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 13467370
• Report Number: 3005168196-2022-00041
• Device Sequence Number: 20142008
• Product Code: HCG
• UDI-Device Identifier: 00814548015330
• UDI-Public: 00814548015330
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/06/2022
• 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: 04/04/2026
• Device Model Number: 400SMTXSFT2H06
• Device Catalogue Number: 400SMTXSFT2H06
• Device Lot Number: F105147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• 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: 01/10/2022
• Initial Report FDA Received Date: 02/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2021
• 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