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

Catalog Number	400SMTXSFT2H06
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2023
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery (acom) using a penumbra smart coil (smart coil), a smart coil detachment handle (handle) and a non-penumbra microcatheter.It was noted that the patient¿s anatomy was tortuous.During the procedure, the physician advanced the smart coil into the target location and attempted to detach it using the handle; however, the smart coil would not detach.The physician then attempted to manually detach the coil but the smart coil still would not detach.Therefore, the physician decided to retract the smart coil.While retracting, the smart coil unintentionally detached in the microcatheter.Subsequently, the physician pushed the detached smart coil into the target vessel using the pusher assembly.The procedure was completed using non-penumbra coils and a non-penumbra handle.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 its pusher assembly.Evaluation revealed that the pet lock was separated on the proximal end of the pusher assembly, the pull wire was retracted out of the distal tip of the pusher assembly, and the embolization coil was detached.This typically occurs during a detachment attempt.Further evaluation revealed that an unknown substance was present inside the pusher assembly distal tip.The unknown substance may have contributed to the coil not detaching initially during the procedure.The root cause of the reported complaint could not be determined.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.
Additional Manufacturer Narrative
Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of the reported complaint due to the return condition.

• 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: 17056628
• Report Number: 3005168196-2023-00257
• Device Sequence Number: 5178121
• Product Code: HCG
• UDI-Device Identifier: 00814548015330
• UDI-Public: 814548015330
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/14/2023
• 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 Catalogue Number: 400SMTXSFT2H06
• Device Lot Number: F00000943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/09/2023
• Supplement Date Received by Manufacturer: 06/13/2023; 01/14/2005
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 07/05/2023; 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2022
• 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: 74 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005