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

Model Number	400SMTXSFT2H03
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned smart coil could not confirm the reported difficulty coil detachment issue.Evaluation revealed that the proximal end of the pull wire was fractured, the pull wire was retracted from the pusher assembly ddt and the embolization coil was detached form the pusher assembly.This damage likely occurred due to the manual coil detachment attempt during the procedure.Due to the returned condition, the device was unable to be functionally tested; therefore, the root cause of reported complaint could not be determined.Further evaluation of the device revealed kinks throughout the pusher assembly.This damage was likely incidental to the complaint.Evaluation of the returned smart coil confirmed that the embolization coil was not detached from the pusher assembly.Evaluation revealed that the proximal end of the pusher assembly and the pull wire were fractured.This damage likely occurred due to the manual coil detachment attempt during the procedure.Due to the pull wire fracture, the device was unable to be functionally tested; therefore, the root cause of the complaint could not be determined.Further evaluation of the device revealed kinks throughout the pusher assembly, and offset coil winds on the embolization coil.This damage was likely incidental to the complaint.Evaluation of the returned smart coil confirmed that the embolization coil was not detached from the pusher assembly.Evaluation revealed that the proximal end of the pull wire was fractured.This damage likely occurred due to the manual coil detachment attempted during the procedure.Due to the pull wire fracture, the device was unable to be functionally tested; therefore, the root cause of the complaint could not be determined.Further evaluation of the device revealed kinks throughout the pusher assembly, and offset coil winds on the embolization coil.This damage was likely incidental to the complaint.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The investigation findings do not lead to a clear conclusion about the root cause of the reported complaint due to the return condition.This report is associated with mfr report numbers: 3005168196-2021-02654, 3005168196-2021-02655, 3005168196-2021-02657.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery using penumbra smart coils (smart coils), a penumbra smart coil detachment handle (handle), and a non-penumbra microcatheter.During the procedure, the physician placed two smart coils in the target vessel using the microcatheter.The next smart coil would not advance at all from its initial position within its introducer sheath.Therefore, the smart coil was removed.The physician then advanced another smart coil into the target vessel using the microcatheter and attempted to detach it using a handle; however, the smart coil failed to detach.The physician also attempted to press the trigger of the handle halfway while pulling on the pusher assembly, but the smart coil did not detach.Therefore, the physician used forceps to manually detach the smart coil.Subsequently, the next two smart coils would not detach using a new handle.It was also reported that the physician attempted to press the trigger of the handle halfway while pulling on their respective pusher assembly, but the smart coils did not detach.The physician also attempted to use forceps to manually detach the smart coils but was unsuccessful.Therefore, the two smart coils and handle were removed.The procedure was completed using another coil and the same microcatheter.There was no 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: 12856811
• Report Number: 3005168196-2021-02656
• Device Sequence Number: 3993111
• Product Code: HCG
• UDI-Device Identifier: 00814548015316
• UDI-Public: 00814548015316
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 11/22/2021
• 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: 02/24/2026
• Device Model Number: 400SMTXSFT2H03
• Device Catalogue Number: 400SMTXSFT2H03
• Device Lot Number: F104141
• 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: 10/25/2021
• Initial Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2021
• 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: 80 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005