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

Catalog Number	RED72
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the internal carotid artery (ica) using a penumbra system red 72 reperfusion catheter (red72) and a velocity delivery microcatheter (velocity).During the procedure, while initially advancing the red72 to the target vessel, the physician fractured the red72 mid-shaft.The physician then retracted the red72 and upon removal, the physician found that the fractured distal end of the red72 was in the ica.Therefore, the physician used a snare device to remove the fractured piece of red72.The procedure was completed using the same velocity and a non-penumbra catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned red 72 confirmed a fracture on the distal length of the device.If the red 72 is advanced against resistance, damage such as a kink may occur.Further manipulation of a kinked device may cause additional resistance during attempted retraction.Retraction of a damage device may cause the device to stretch and fracture.The distal fractured segment was not returned for evaluation.Further evaluation of the device revealed an additional kink.This damage was likely incidental to the complaint.Penumbra catheters 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
Please note that this complaint was submitted to the fda by the user facility with the following reference number: (b)(4).The following sections are being updated based on additional information included in the user facility report submitted to the fda: 1.Section e.Box 4.Initial reporter also sent report to fda.2.Section g.Box 3.Report source h3 other text : placeholder.

• 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: 15070652
• Report Number: 3005168196-2022-00346
• Device Sequence Number: 14780970
• Product Code: NRY
• UDI-Device Identifier: 00815948023918
• UDI-Public: 815948023918
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2022
• 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: 03/03/2025
• Device Catalogue Number: RED72
• Device Lot Number: H12722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2022
• 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: 07/14/2022
• Supplement Date Received by Manufacturer: 08/02/2022
• Initial Report FDA Received Date: 07/20/2022
• Supplement Report FDA Received Date: 08/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2022
• 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 Sex: Female
• Date Report Sent to FDA: 01/01/2005