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

Model Number	400SMTSFT0820
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2021
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: 3005168196-2021-01571.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right internal carotid artery using penumbra smart coils (smart coil), a penumbra smart coil detachment handle (handle), a non-penumbra microcatheter, and a guidewire.During the procedure, the physician successfully detached three smart coils in the target vessel using the handle.While attempting to detach the fourth smart coil, the smart coil failed to detach after several attempts.Therefore, the physician manually detached the smart coil.Next, the physician successfully detached nine smart coils in the target vessel using the same handle.While attempting to detach the next smart coil, the same issue occurred.Therefore, the physician also manually detached the smart coil.The procedure was completed at this point.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 was detached from the pusher assembly.Further evaluation revealed that the pet lock was broken on the proximal end of the pusher assembly and the pull wire was retracted from the pusher assembly ddt.This damage was likely occurred due to the manual detachment attempted during the procedure.If the pet lock is broken, and the pull wire is retracted from the ddt, the embolization will detach from its pusher assembly.The detached embolization coil was not returned for evaluation.Based on the returned condition, the root cause of the smart coil failure to detach during the procedure could not be determined.Evaluation of the returned smart coil confirmed that the embolization coil was detached from the pusher assembly.Further evaluation revealed that the pet lock was broken on the proximal end of the pusher assembly and the pull wire was retracted from the pusher assembly ddt.This damage was likely occurred due to the manual detachment attempted during the procedure.If the pet lock is broken, and the pull wire is retracted from the ddt, the embolization will detach from its pusher assembly.The detached embolization coil was not returned for evaluation.Based on the returned condition, the root cause of the smart coil failure to detach during the procedure could not be determined.Penumbra coils are visually 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 failure to detach due to the returned condition.This report is associated with mfr report number: 3005168196-2021-01571 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: 12186057
• Report Number: 3005168196-2021-01570
• Device Sequence Number: 16394060
• Product Code: HCG
• UDI-Device Identifier: 00814548014753
• UDI-Public: 00814548014753
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• 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): 08/03/2021
• 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: 03/23/2026
• Device Model Number: 400SMTSFT0820
• Device Catalogue Number: 400SMTSFT0820
• Device Lot Number: F104836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/21/2021
• Supplement Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 07/16/2021
• Supplement Report FDA Received Date: 08/03/2021
• 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
• Patient Weight: 65
• Date Report Sent to FDA: 01/01/2005