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

Model Number	400SMTXSFT4H12
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the posterior cerebral arteries (pca) using penumbra smart coils (smart coil) and a non-penumbra microcatheter.During the procedure, the smart coil would not advance from the starting position within its introducer sheath, and subsequently the physician kinked the pusher assembly of the smart coil.Therefore, the smart coil was removed.The procedure was completed using a new smart coil.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 12960519
• Report Number: 3005168196-2021-02771
• Device Sequence Number: 20189492
• Product Code: HCG
• UDI-Device Identifier: 00814548017204
• UDI-Public: 00814548017204
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/08/2021
• 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: 10/19/2025
• Device Model Number: 400SMTXSFT4H12
• Device Catalogue Number: 400SMTXSFT4H12
• Device Lot Number: F101274
• Was Device Available for Evaluation?: No
• 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: 11/10/2021
• Initial Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2020
• 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