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

Model Number	400SMTXSFT0410
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
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2021-02586.
Event or Problem Description
The patient was undergoing a coil embolization procedure using a penumbra smart coil (smart coil) and a penumbra smart coil detachment handle (handle).During the procedure, the physician attempted to detach the smart coil using the handle; however, the smart coil failed to detach.Therefore, the smart coil was removed.No additional information regarding the completion of the procedure was provided.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned smart coil revealed, that the embolization coil was detached from the pusher assembly.And not returned for evaluation.Therefore, the reported complaint could not be confirmed.Evaluation revealed, that the pet lock was separated, and the pull wire was retracted out the pusher assembly and was fractured.Further evaluation revealed, that the braided shaft on the distal shaft of the pusher assembly was delaminated.The cause of this damage could not be determined.However, this damage may have contributed to the detachment issue, during the procedure.Further evaluation also revealed, bends and kinks throughout the length of the pusher assembly.This damage was likely incidental to the reported complaint.And may have occurred, during packaging for return to penumbra.Evaluation of the returned handle revealed, an undamaged functional device.The handle was used to detach a demonstration smart coil without an issue.Due to the return condition of the complaint smart coil, the root cause of the detachment issue, during the procedure could not be determined.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.Penumbra handles are 100% visually inspected and functionally tested, during incoming quality inspection.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 the smart coils failure to detach.This report is associated with mfr report number: 1.3005168196-2021-02586.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: 12817311
• Report Number: 3005168196-2021-02585
• Device Sequence Number: 5647327
• Product Code: HCG
• UDI-Device Identifier: 00814548015408
• UDI-Public: 00814548015408
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 12/06/2021
• 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: 01/07/2026
• Device Model Number: 400SMTXSFT0410
• Device Catalogue Number: 400SMTXSFT0410
• Device Lot Number: F103174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• 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
• Supplement Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 12/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2021
• 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 Sex: Unknown
• Date Report Sent to FDA: 01/01/2005