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

Model Number	400SMTXSFT0101
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
Type of Reportable Event	Malfunction
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.This report is associated with mfr report numbers: 3005168196-2021-02196, 3005168196-2021-02197.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat cervical meningioma using penumbra smart coils (smart coil), penumbra smart coil detachment handles (handle), benchmark 6f 071 delivery catheter (benchmark), a non-penumbra microcatheter and a guidewire.During the procedure, the physician advanced a smart coil in the target vessel and made multiple attempts to detach the smart coil using the first handle; however, the smart coil failed to detach.A second handle was then used but had the same issue; subsequently, the physician made several attempts to manually detach the smart coil but it still would not detach.Therefore, the smart coil was retracted.However, while retracting, the smart coil unintentionally detached into the distal of the microcatheter.The physician then pushed the smart coil with the pusher wire into the target location.The procedure was completed using non-penumbra coils, the same benchmark 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: 12572757
• Report Number: 3005168196-2021-02198
• Device Sequence Number: 17016038
• Product Code: HCG
• UDI-Device Identifier: 00814548015163
• UDI-Public: 00814548015163
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/04/2021
• 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: 05/11/2026
• Device Model Number: 400SMTXSFT0101
• Device Catalogue Number: 400SMTXSFT0101
• Device Lot Number: F106158
• Was Device Available for Evaluation?: No
• 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: 09/09/2021
• Initial Report FDA Received Date: 10/04/2021
• 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