MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED72 REPERFUSION CATHETER; NRY

Catalog Number	RED72KIT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra system red 72 reperfusion catheter (red72), a velocity delivery microcatheter (velocity), a non-penumbra guide sheath, a rotating hemostasis valve (rhv), and a microwire.During the procedure, the physician advanced the red72 and the velocity over the microwire and through the guide sheath to the target location.The physician then removed the velocity and the microwire and retracted the red72 for repositioning.While attempting to complete a first pass, the physician heard a sound and noticed that the red72 was fractured at the proximal location.It was reported that the hospital technologist may have overtightened the rhv prior to retracting the red72.The red72 and the rhv were removed and not used for the remainder of the procedure.The procedure was completed using a penumbra system red 68 reperfusion catheter (red68), the same velocity, the same guide sheath, another rhv, and the same microwire.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned red72 confirmed a fracture on the proximal end, and the proximal fractured segment was returned inside the rhv.If the device is retracted against resistance, damage such as a fracture may occur.Evaluation also revealed an ovalization proximal to the fracture.It was reported that the rhv may have been overtightened prior to retraction of the red72.This likely contributed to the ovalization and resistance during retraction.Further evaluation revealed kinks on the proximal end.This damage may have occurred during packaging for return to penumbra.Penumbra products 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.

• Brand Name: PENUMBRA SYSTEM RED72 REPERFUSION CATHETER
• Common Device Name: NRY
• 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: 17410277
• Report Number: 3005168196-2023-00352
• Device Sequence Number: 7493284
• Product Code: NRY
• UDI-Device Identifier: 00815948023932
• UDI-Public: 815948023932
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K211654
• 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): 07/27/2023
• 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 Expiration Date: 01/03/2026
• Device Catalogue Number: RED72KIT
• Device Lot Number: H00001805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2023
• 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: 07/05/2023
• Initial Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2023
• 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: 69 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005