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

Catalog Number	400SMTXSFT1H04
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2022
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 in the supraclinoid segment of the internal carotid artery (ica) using a penumbra smart coil (smart coil), a penumbra smart coil handle (handle), and a non-penumbra microcatheter.During the procedure, the physician advanced the smart coil using the microcatheter to the target vessel and attempted to detach it using the handle; however, the smart coil failed to detach.Subsequently, the physician attempted to manually detach the smart coil; however, they were still unsuccessful.Therefore, the physician began retracting the smart coil; however, the smart coil unintentionally detached in the microcatheter.Therefore, the microcatheter containing the detached smart coil was removed.The smart coil was flushed out of the microcatheter on the back table and the microcatheter was then reinserted into the patient.The procedure was completed using a new smart coil and the same non-penumbra 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: 14527204
• Report Number: 3005168196-2022-00243
• Device Sequence Number: 6149911
• Product Code: HCG
• UDI-Device Identifier: 00814548015248
• UDI-Public: 814548015248
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/27/2022
• 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: 09/22/2026
• Device Catalogue Number: 400SMTXSFT1H04
• Device Lot Number: F109362
• 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: 05/03/2022
• Initial Report FDA Received Date: 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2021
• 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 Age: 61 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005