MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER; NRY

Catalog Number	RED72
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the internal carotid artery (ica) to treat a total occlusion using a penumbra system red 72 reperfusion catheter (red72), a stent retriever, and a non-penumbra sheath.During the procedure, the physician successfully completed one pass with the red72 and the stent retriever.While advancing the stent retriever through the red72 during the second pass, the physician experienced resistance but continued to complete the pass.While removing the red72 and the stent retriever from the patient, the stent retriever became caught inside the red72.After removal, the physician found that the red72 was fractured.The procedure was completed using a penumbra system red 62 reperfusion catheter (red62), a stent retriever, and the same sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Additional Manufacturer Narrative
Evaluation of the returned red72 confirmed that the catheter was fractured, the internal coil winds were unraveled, and the non-penumbra stent retriever was tangled within the coil winds.Based on the reported event, the physician encountered resistance while advancing the stent retriever, but it was continued to be advanced against resistance through the red72 to complete the second pass.Subsequent retraction of the stent retriever within the red72 may have contributed to the fracture and the unraveled internal coil winds.Further evaluation of the red72 revealed kinks along the distal shaft and ovalization at the distal end.This damage was not mentioned in the reported complaint and is likely incidental.The root cause of this damage could not be determined.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 RED 72 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: 18545257
• Report Number: 3005168196-2023-00538
• Device Sequence Number: 15744044
• Product Code: NRY
• UDI-Device Identifier: 00815948023918
• UDI-Public: 815948023918
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K211654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2024
• 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: 06/08/2026
• Device Catalogue Number: RED72
• Device Lot Number: H00002986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/05/2024
• Supplement Date Received by Manufacturer: 01/05/2024
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2023
• 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: 74 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005