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

Model Number	400SMTSFT0930
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2021
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a wide neck middle cerebral artery aneurysm using penumbra smart coils (smart coils), a penumbra smart coil detachment handle (handle), a non-penumbra microcatheter, and a non-penumbra bifurcation aneurysm implant device.During the procedure, the physician placed a bifurcation aneurysm implant device into the aneurysm using the microcatheter.Next, the physician advanced a smart coil into the target vessel using the microcatheter and attempted to detach it using the handle; however, the smart coil failed to detach.The physician made two additional attempts; however, the smart coil did not detach.The physician attempted to manually detach the smart coil; however, it would not detach.Therefore, the physician decided to remove the smart coil.Upon removal, the smart coil unintentionally detached with approximately the last three centimeters of the smart coil in the microcatheter.The physician used the pusher assembly of the smart coil to push the detached smart coil into the target location.The procedure was completed using additional smart coils, the same handle, 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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 12833996
• Report Number: 3005168196-2021-02597
• Device Sequence Number: 4473033
• Product Code: HCG
• UDI-Device Identifier: 00814548014784
• UDI-Public: 00814548014784
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/17/2021
• 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: 04/22/2025
• Device Model Number: 400SMTSFT0930
• Device Catalogue Number: 400SMTSFT0930
• Device Lot Number: F97491
• 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: 10/20/2021
• Initial Report FDA Received Date: 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2020
• 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: Female
• Date Report Sent to FDA: 01/01/2005