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

Model Number	400SMTXSFT0304
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2021
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 numbers: 3005168196-2021-01685, 3005168196-2021-01687, 3005168196-2021-01688.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the m2 segment of the middle cerebral artery (mca) using penumbra smart coils (smart coils), penumbra smart coil detachment handles (handles), and a non-penumbra microcatheter.During the procedure, the physician advanced a smart coil into the target vessel and used the handle to detach it; however, the smart coil failed to detach.The physician then attempted to detach the smart coil using a second handle, but it was unsuccessful.Next, the physician attempted to manually detach the smart coil by hand, but it was also unsuccessful.Therefore, the smart coil was removed.Afterwards, the physician advanced a second smart coil into the target vessel and attempted to detach it using the same handle; however, the same issue occurred.Therefore, the smart coil and handle were removed.The procedure was completed using other coil and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned smart coil confirmed that the embolization coil would not detach from the pusher assembly.Further evaluation of the device revealed that the pet lock was broken, the pull wire and the pusher assembly were fractured at their proximal end, the pusher assembly was kinked near the fractured location and the pull wire was slightly retracted from the pusher assembly ddt.These damages were likely a result of the coil detachment attempts during the procedure.Due to the pull wire fracture, the device was unable to be functionally tested; therefore, the root cause of the reported complaint could not be determined.Further evaluation of the device also revealed 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 would not detach from the pusher assembly.Further evaluation of the device revealed that the pet lock was broken, the pull wire was fractured at its proximal end, the pusher assembly was kinked near its proximal end and the pull wire was slightly retracted from the pusher assembly ddt.These damages were likely a result of the coil detachment attempts during the procedure.Due to the pull wire fracture, the device was unable to be functionally tested; therefore, the root cause of the reported complaint could not be determined.Further evaluation of the device also revealed offset coil winds on the embolization coil and the additional kinks in the pusher assembly.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.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 coil''s failure to detach.This report is associated with mfr report numbers: 1.3005168196-2021-01685, 2.3005168196-2021-01687, 3.3005168196-2021-01688.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12249167
• Report Number: 3005168196-2021-01686
• Device Sequence Number: 14170827
• Product Code: HCG
• UDI-Device Identifier: 00814548015347
• UDI-Public: 00814548015347
• Combination Product (Y/N): Y
• Initial Reporter Country: GR
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2021
• 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: 400SMTXSFT0304
• Device Catalogue Number: 400SMTXSFT0304
• Device Lot Number: F103171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 07/29/2021
• Supplement Report FDA Received Date: 09/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005