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

Model Number	400SMTHXSFT0415
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2020
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: 3005168196-2020-02146 and 3005168196-2020-02148.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the basilar artery using penumbra smart coils (smart coil) and non-penumbra microcatheter.During the procedure, three smart coils were placed in the target vessel using the non-penumbra microcatheter; however, it was reported that the friction lock for all three smart coils were not working and the smart coils were loose within the introducer sheath.Next, the physician advanced another smart coil into the vessel and attempted to detach it using a handle; however, the smart coil failed to detach.Therefore, the physician decided to remove the smart coil.While retracting the pusher assembly, the smart coil unintentionally detached inside of the microcatheter.The physician then pushed the detached smart coil into the aneurysm using the pusher assembly and implanted the coil.Subsequently, another smart coil was advanced into the vessel and the physician attempted to detach it using the handle; however, the smart coil failed to detach.Therefore, the smart coil and handle was removed.The physician then advanced a new smart coil into a bowl of saline on the back table; however, the smart coil would not advance past the friction lock within the introducer sheath.The issue with the smart coil occurred prior to use and, therefore, it was not used in the procedure.The procedure was completed using additional smart coils, a new handle, and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the first returned smart coil revealed that the pet lock was fractured off the proximal end of the pusher assembly, and the pull wire was retracted out of the ddt.This damage likely resulted in the embolization coil detaching from its pusher assembly.Based on the returned condition of the device, the root cause of the reported detachment issue could not be determined.Evaluation of the returned handle revealed a functional device.During the functional test, the handle was functionally tested on the handle fixture and passed within specification.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of coil detachment.This report is associated with mfr report numbers: 1.3005168196-2020-02146 2.3005168196-2020-02148.H3 other text : placeholder.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10931801
• Report Number: 3005168196-2020-02147
• Device Sequence Number: 16279937
• Product Code: HCG
• UDI-Device Identifier: 00814548015842
• UDI-Public: 00814548015842
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2020
• 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: 05/03/2025
• Device Model Number: 400SMTHXSFT0415
• Device Catalogue Number: 400SMTHXSFT0415
• Device Lot Number: F97665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 12/02/2020
• Supplement Report FDA Received Date: 03/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Date Report Sent to FDA: 01/01/2005