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

Model Number	400SMTHXSFT0103
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2021
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: 3005168196-2021-02222, 3005168196-2021-02223, 3005168196-2021-02225.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left a1 segment of the anterior cerebral artery (aca) using penumbra smart coils (smart coil), a penumbra smart coil detachment handle (handle) and a non-penumbra microcatheter.It was noted that the patient¿s anatomy was very tortuous.During the procedure, the physician advanced a smart coil into the target vessel and attempted to detach it using the handle; however, the smart coil failed to detach.The physician then attempted to manually detach the smart coil, but was unsuccessful.Therefore, the smart coil was removed.It was reported that the same issue occurred with the next two smart coils.Therefore, the smart coils were also removed.The procedure was completed using other coils 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 confirmed, that the embolization coil was intact with the pusher assembly.And had offset coil winds.Evaluation revealed, that the pull wire and pusher assembly were fractured on the proximal end of the pusher assembly, and the pull wire was present in the pusher assembly ddt.This indicates that the pull wire may have become fractured somewhere inside the pusher assembly.This damage was likely, a result of the detachment attempts made, during the procedure.The root cause of the detachment failure could not be determined.Further evaluation revealed, a kink on the pusher assembly braided shaft.This damage may be incidental to the reported complaint and may have occurred, during packaging for return to penumbra.Evaluation of the second returned smart coil confirmed, that the embolization coil was intact with the pusher assembly.And had offset coil winds.Evaluation revealed, that the pet lock was separated, the pull wire was not present on the proximal end of the pusher assembly, and the pull wire was present in the pusher assembly ddt.This indicates that the pull wire may have become fractured, somewhere inside the pusher assembly.This damage was likely, a result of the detachment attempts made, during the procedure.The root cause of the detachment failure could not be determined.Further evaluation revealed, pusher assembly kinks and a fracture.This damage may be incidental to the reported complaint and may have occurred, during packaging for return to penumbra.Evaluation of the third returned smart coil confirmed, that the embolization coil was intact with the pusher assembly.And had offset coil winds.Evaluation revealed, that the pet lock was separated, the pull was not present on the proximal end of the pusher assembly, and the pull wire was present in the pusher assembly ddt.This indicates that the pull wire may have become fractured, somewhere inside the pusher assembly.This damage was likely, a result of the detachment attempts made, during the procedure.The root cause of the detachment failure could not be determined.Further evaluation revealed, kinks along the length of the pusher assembly and on the braided shaft.This damage may be incidental to the reported complaint and may have occurred, during packaging for return to penumbra.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.This report is associated with mfr report numbers: 1.3005168196-2021-02222; 2.3005168196-2021-02223; 3.3005168196-2021-02225.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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 12600750
• Report Number: 3005168196-2021-02224
• Device Sequence Number: 3473717
• Product Code: HCG
• UDI-Device Identifier: 00814548015620
• UDI-Public: 00814548015620
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 12/02/2021
• 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: 04/26/2026
• Device Model Number: 400SMTHXSFT0103
• Device Catalogue Number: 400SMTHXSFT0103
• Device Lot Number: F105760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• 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: 09/14/2021
• Supplement Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 10/08/2021
• Supplement Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2021
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 74 KG
• Date Report Sent to FDA: 01/01/2005