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

Catalog Number	400SMTHXSFT1H03
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior cerebral artery (aca) using penumbra smart coils (smart coils), a penumbra smart coil handle (handle), and a non-penumbra microcatheter.During the procedure, the physician successfully implanted two smart coils using the microcatheter.Next, physician advanced the third 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 then attempted to detach the smart coil using a new handle, but the smart coil would still not detach.Afterwards, the physician attempted to manually detach the smart coil but was unsuccessful.Therefore, the smart coil was removed.Next, the physician successfully implanted the fourth and the fifth smart coils using the microcatheter and the second handle.The physician then advanced a sixth smart coil into the target vessel using the microcatheter and attempted to detach it using both handles; however, the smart coil failed to detach.Next, the physician attempted to manually detach the smart coil but was unsuccessful.Therefore, the physician decided to remove the smart coil.Upon retraction, the smart coil unintentionally detached.The physician then used the pusher assembly of the smart coil to successfully push the detached smart coil into the target vessel.The procedure was completed at this point.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: 16449219
• Report Number: 3005168196-2023-00091
• Device Sequence Number: 5834844
• Product Code: HCG
• UDI-Device Identifier: 00814548015668
• UDI-Public: 814548015668
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/27/2023
• 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 Catalogue Number: 400SMTHXSFT1H03
• Device Lot Number: F113247
• 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: 02/02/2023
• Initial Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• 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 Age: 66 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Date Report Sent to FDA: 01/01/2005