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

Catalog Number	400SMTXSFT0306
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The smart coil was implanted in the patient; however, the pusher assembly is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the prostatic artery using penumbra smart coils (smart coils), a penumbra smart coil handle (handle), and a non-penumbra microcatheter.During the procedure, the physician delivered an embolization agent in the target vessel using the microcatheter.Afterwards, while advancing a smart coil through the microcatheter into the target vessel, the smart coil became stuck.Therefore, the physician decided to remove the smart coil.Upon retraction, the smart coil unintentionally detached with part of the smart coil in the target vessel and the other part in the microcatheter.Therefore, the physician flushed the remaining part of the smart coil out of the microcatheter and into the target vessel.Next, the physician advanced another smart coil into the target vessel using the microcatheter and attempted to detach it using the handle; however, the smart coil failed to detach.Therefore, the physician manually detached the smart coil.No additional information regarding the completion of the procedure was provided.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report: 3005168196-2023-00069.Section b.Box 3.Date of event.Evaluation of the returned smart coil revealed that the pet lock was separated, the pull wire was retracted, and the embolization coil was detached.Evaluation could not confirm the root cause of the reported unintentional detachment due to the returned condition.The detached embolization coil was not returned for evaluation.Further evaluation of the device revealed kinks on the pusher assembly.This damage was likely incidental to the complaint and occurred during packaging for the device return.Penumbra products are visually inspected during in-process inspection and during quality inspection after manufacturing.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.

• 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: 16329771
• Report Number: 3005168196-2023-00069
• Device Sequence Number: 12459888
• Product Code: HCG
• UDI-Device Identifier: 00814548015354
• UDI-Public: 814548015354
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 07/29/2023
• 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: 400SMTXSFT0306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/10/2023
• Supplement Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 07/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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