MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA COIL 400; HCG, KRD

Catalog Number	4006C0404
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned pc400 confirmed that the embolization coil was detached from the pusher assembly.Evaluation revealed that the pet lock was separated, and the pull wire was retracted at the proximal end of the pusher assembly.This likely occurred due to the detachment attempts during the procedure.Further evaluation revealed that the pusher assembly was kinked throughout its length and fractured, the pull wire was retracted from the fractured location on the pusher assembly and the embolization coil had offset coil winds.This damage was likely incidental to the complaint.Due to the returned damage, the root cause of the reported detachment issue 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.4316 - the investigation findings do not lead to a clear conclusion about the root cause of unintentional detachment of the pc400.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a pericallosal artery aneurysm using a penumbra coil 400 (pc400), penumbra coil 400 detachment handle (handle), px slim delivery microcatheter (px slim), and a non-penumbra stent.During the procedure, the physician placed the px slim behind the non-penumbra stent and then advanced a pc400 into the aneurysm and attempted to detach it using a handle; however, the pc400 failed to detach.It was reported that the physician pulled hard on the pusher assembly of the pc400 and made several attempts to detach the pc400 using the handle, but the coil would not detach.Therefore, the physician decided to remove the pc400.Subsequently, while retracting the pc400 back into the px slim, the pc400 unintentionally detached inside the px slim.The physician, therefore removed the px slim containing the detached pc400.The procedure had ended at this point.The physician plans to attempt re-coil the aneurysm at a different date.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA COIL 400
• 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: 16583277
• Report Number: 3005168196-2023-00115
• Device Sequence Number: 12015620
• Product Code: HCG
• UDI-Device Identifier: 00814548018201
• UDI-Public: 814548018201
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• 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
• Report Date (Section B): 03/21/2023
• 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: 4006C0404
• Device Lot Number: F00000821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2023
• 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: 02/23/2023
• Initial Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/01/2005