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

Model Number	400SMTHXSFT0204
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device 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 basilar artery using penumbra smart coils (smart coil), penumbra smart coil detachment handles (handle), a non-penumbra microcatheter, a 5f diagnostic catheter, and a guidewire.During the procedure, the physician advanced a smart coil to the target vessel and attempted to detach it using a handle; however, the smart coil failed to detach.Therefore, the smart coil was removed.Subsequently, the same issue occurred with eight other smart coils.It was reported that attempts were made to detach the smart coils with three different handles.The procedure was completed using new smart coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned smart coil could not confirm the reported complaint.Evaluation revealed that the pet lock was separated, and the embolization coil was detached from the pusher assembly and was not returned for evaluation.Based on the return condition, the root cause of the detachment issue during the procedure could not be determined.Further evaluation revealed pusher assembly kinks.This damage was likely incidental to the complaint.Please note that the following section is being updated based on additional information provided by a penumbra sales representative on 27-jan-2022: 1.Section b.Box 5.Describe event or problem please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report:3005168196-2021-02393.1.Section d.Box 4.Lot number, catalog number, expiration date, unique identifier 2.Section h.Box 4.Device manufacture date this report is associated with mfr report numbers: 1.3005168196-2021-02388, 2.3005168196-2021-02389, 3.3005168196-2021-02390, 4.3005168196-2021-02391, 5.3005168196-2021-02392, 6.3005168196-2021-02394, 7.3005168196-2021-02396, 8.3005168196-2021-02398, 9.3005168196-2021-02399, 10.3005168196-2021-02401, 11.3005168196-2021-02402 h3 other text : placeholder.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the basilar artery using penumbra smart coils (smart coil), a penumbra smart coil detachment handle (handle), a non-penumbra microcatheter, a 5f diagnostic catheter, and a guidewire.During the procedure, the physician advanced a smart coil to the target vessel and attempted to detach it using the handle; however, the smart coil failed to detach.Therefore, the smart coil was removed.Subsequently, the same issue occurred with five other smart coils.It was reported that attempts were made to detach the smart coils with three different handles.The procedure was completed using new smart coils and a new handle.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: 12701087
• Report Number: 3005168196-2021-02393
• Device Sequence Number: 4028031
• Product Code: HCG
• UDI-Device Identifier: 00814548015712
• UDI-Public: 00814548015712
• Combination Product (Y/N): Y
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2022
• 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: 03/05/2024
• Device Model Number: 400SMTHXSFT0204
• Device Catalogue Number: 400SMTXSFT0204
• Device Lot Number: F88919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• 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: 09/28/2021
• Supplement Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 10/26/2021
• Supplement Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2019
• 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