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

Catalog Number	4006C0410
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned pc400 confirmed that the embolization coil was detached from the pusher assembly.Further evaluation revealed that the pet lock was separated, and the pull wire was retracted from its initial position inside the pusher assembly.This typically occurs during a successful detachment.Based on the reported complaint, the root cause of the pet lock becoming separated and pull wire being retracted could not be determined.Further evaluation revealed ovalization throughout the distal length of the pusher assembly and offset coil winds on the embolization coil.This damage was incidental to the complaint and the root cause 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the carotid-cavernous fistula (ccf) using a penumbra coil 400 (pc400), a px slim delivery microcatheter (px slim), a benchmark bmx96 access system (bmx96), a non-penumbra catheter, a non-penumbra microcatheter, and a non-penumbra coil.During the procedure, the physician obtained transvenous access using the bmx96 and non-penumbra catheter.The physician placed a non-penumbra microcatheter and px slim side by side into the distal portion of the fistula and then, advanced a pc400 into the target vessel, but determined the pc400 was too large for the vessel and was removed.Next, a smaller pc400 was advanced into the fistula; however, the physician noticed the pc400 was also too large for the vessel and the coil would move back into the cavernous sinus and out of the fistula due to the high flow.The physician pulled the entire pc400 back into the px slim with the coil still visible at the tip of the px slim.The physician then advanced the non-penumbra coil through the other microcatheter.It was reported that the px slim containing the pc400 was superimposed on the other microcatheter, and the physician was unable to visualize the proximal marker band of the non-penumbra microcatheter.The physician decided to pull back on the pc400 within the px slim out from visualization and advanced the non-penumbra coil further into the fistula.Prior to detaching the other coil in the target location, the physician decided to remove the pc400 from the px slim; however, upon pulling the pusher assembly of the pc400, the physician noticed the pc400 had unintentionally detached inside the px slim.The px slim was removed containing the detached pc400 and the coil was flushed out.The physician decided not to use the px slim for the remainder of the procedure.The procedure was completed using an additional new non-penumbra microcatheter, same microcatheter, same bmx96, and same catheter and new non-penumbra coils.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: 17865906
• Report Number: 3005168196-2023-00451
• Device Sequence Number: 20705422
• Product Code: HCG
• UDI-Device Identifier: 00814548018232
• UDI-Public: 814548018232
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/03/2023
• 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: 4006C0410
• Device Lot Number: F00006140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2023
• 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: 09/08/2023
• Initial Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2023
• 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: 85 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005