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

Catalog Number	4006C0410
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a carotid-cavernous fistula using a penumbra coil 400 (pc400), px slim delivery microcatheter (px slim), benchmark bmx96 access system (bmx96), embolic agent, non-penumbra guide catheter, and a non-penumbra balloon catheter.During the procedure, the physician obtained transarterial access on the left side using the guide catheter and injected three vials of embolic agent in the fistula using the balloon catheter.Next, the physician placed the bmx96 in the right internal jugular going to the right common carotid artery and noticed the inferior petrosal sinus (ips) was no longer visible due to the embolic agent closing off the vein.The physician was unable to navigate around the transverse sinus using the px slim (straight) and guidewire; therefore, the physician decided to remove the px slim (straight) and switch to a new px slim (90).Subsequently, after pulling back on the bmx96 and making multiple attempts to go around, the ips had reopened, and the physician was able to access the cavernous sinus using the px slim.The physician then advanced the pc400 into the target location; however, after forming approximately two and a half loops of the pc400, the physician started to experience resistance when the coil came in contact with the embolic agent.It was reported that the physician thought the pc400 was too large for the space and decided to retract the coil; however, upon retraction, the pc400 unintentionally detached inside the px slim.Therefore, the physician removed the pusher assembly of the pc400 and then reinserted it back into px slim to push the detached pc400 into the cavernous sinus and successfully implanted the coil.The px slim was then removed.The procedure was completed using a new non-penumbra microcatheter and non-penumbra coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• 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: 16478847
• Report Number: 3005168196-2023-00094
• Device Sequence Number: 14252715
• 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
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/03/2023
• 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: F103121
• Was Device Available for Evaluation?: No
• 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: 02/06/2023
• Initial Report FDA Received Date: 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2021
• 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: 67 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005