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	11/03/2021
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: 3005168196-2021-02731, 3005168196-2021-02733.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery using penumbra smart coils (smart coil) and penumbra smart coil detachment handles (handle).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.The physician then attempted to manually detach the smart coil but, the coil still failed to detach.Therefore, the smart coil was removed.Subsequently, the same issue occurred with another smart coil.It was reported that attempts were made to detach the smart coils with two different handles.The procedure was completed using two additional smart coils and the second handle.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned smart coil revealed the pusher assembly was returned stuck inside a non-penumbra microcatheter.The pusher assembly was able to be removed with resistance.Further evaluation revealed the pusher assembly was fractured on its proximal end, the pull wire was retracted from the pusher assembly ddt, and the embolization coil was detached.This damage was likely due to the manual detachment during the procedure.Evaluation of the non-penumbra microcatheter revealed an ovalization.This damage may have contributed to resistance while advancing the smart coil and the root cause could not be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.This report is associated with mfr report numbers: 1.3005168196-2021-02731.2.3005168196-2021-02733 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: 12921167
• Report Number: 3005168196-2021-02732
• Device Sequence Number: 17389164
• Product Code: HCG
• UDI-Device Identifier: 00814548015712
• UDI-Public: 00814548015712
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2022
• 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: 05/11/2026
• Device Model Number: 400SMTHXSFT0204
• Device Catalogue Number: 400SMTHXSFT0204
• Device Lot Number: F106149
• 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: 11/08/2021
• Supplement Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2021
• 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: 64 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005