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

Catalog Number	RED72
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a penumbra system red72 reperfusion catheter (red72) and a benchmark bmx96 access system (bmx96).During the procedure, the physician made the first pass at the target location using the red72.Subsequently, while removing the red 72, the physician broke the red72 at the hub transition point.Therefore, the red72 was not used for the remainder of the procedure.The procedure was completed using a penumbra system red 68 reperfusion catheter (red68) and the same benchmark max to achieve thrombolysis in cerebral infarction (tici) 3.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Additional Manufacturer Narrative
Evaluation of the returned red72 confirmed a fracture distal to the strain relief.This type of damage may occur if the device is manipulated during retraction.If the proximal end of red72 is mishandled during retraction, damage such as a kink and subsequent fracture may occur.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.

• 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: 16159765
• Report Number: 3005168196-2023-00024
• Device Sequence Number: 15193176
• Product Code: NRY
• UDI-Device Identifier: 00815948023918
• UDI-Public: 815948023918
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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,Followup
• Report Date (Section B): 01/25/2023
• 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: 09/22/2025
• Device Catalogue Number: RED72
• Device Lot Number: H00001197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2022
• 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: 12/19/2022
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2022
• 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: Unknown
• Date Report Sent to FDA: 01/01/2005