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

Catalog Number	RED72KIT
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2022
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra system red72 reperfusion catheter (red72), a non-penumbra microcatheter, and a non-penumbra sheath.During the procedure, the physician made one pass using the red72.Subsequently, while advancing the red72 past the carotid t to make the next pass, the physician experienced resistance and decided to retract the red72.However, upon retracting, the physician noticed the midshaft towards the distal end of the red72 had broken off under angiography.Therefore, the physician used a snare device to remove the broken piece of the red72 out from the patient.The procedure was completed using a non-penumbra catheter, non-penumbra stent retriever, and the same sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned red72 confirmed a fracture on the distal shaft.Evaluation revealed that the red72 was stretched proximal to the fractured location.This indicated that the device was stretched prior to fracture.This damage typically occurs due to being retracted against resistance.If the device is retracted against resistance, it may become stretched and subsequently fracture.The root cause of the resistance experienced during the procedure could not be determined.Further evaluation revealed kinks on the catheter shaft.This damage was likely incidental to the reported complaint.The distal fractured segment was not returned for evaluation.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.H3 other text : placeholder.

• 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: 16092696
• Report Number: 3005168196-2022-00617
• Device Sequence Number: 6651576
• Product Code: NRY
• UDI-Device Identifier: 00815948023932
• UDI-Public: 815948023932
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 01/24/2023
• 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: 03/29/2025
• Device Catalogue Number: RED72KIT
• Device Lot Number: H12878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2022
• 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: 12/11/2022
• Supplement Date Received by Manufacturer: 12/28/2022
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2022
• 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