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

Model Number	400SMTXSFT0304
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.This report is associated with mfr report numbers.
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
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.Based on additional information received, it was reported that there was no allegation on this device.It was initially understood that twelve devices were involved with the case.However, additional clarification indicated that only nine devices were related to the case.This device is not complaint related and, therefore, not a reportable event.This report is associated with mfr report numbers: 1.3005168196-2021-02388.2.3005168196-2021-02389.3.3005168196-2021-02390.4.3005168196-2021-02391.5.3005168196-2021-02392.6.3005168196-2021-02393.7.3005168196-2021-02394.8.3005168196-2021-02398.9.3005168196-2021-02399.10.3005168196-2021-02401.11.3005168196-2021-02402 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: 12701144
• Report Number: 3005168196-2021-02396
• Device Sequence Number: 4028032
• Product Code: HCG
• UDI-Device Identifier: 00814548015347
• UDI-Public: 00814548015347
• 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): 02/01/2022
• 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: 11/23/2025
• Device Model Number: 400SMTXSFT0304
• Device Catalogue Number: 400SMTXSFT0304
• Device Lot Number: F102275
• Was Device Available for Evaluation?: Yes
• 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: 01/14/2005
• Initial Report FDA Received Date: 10/26/2021
• Supplement Report FDA Received Date: 02/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2020
• 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: Unknown
• Date Report Sent to FDA: 01/01/2005