MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER; NRY

Catalog Number	RED62SKIT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned red62 confirmed that the device was fractured on its distal shaft.Evaluation revealed that the red62 was stretched and ovalized proximal to the fracture site, indicating that the red62 had been stretched prior to fracturing.If the red62 is retracted against resistance, the device may become stretched, ovalized and subsequently fracture.Further evaluation of the red62 revealed a polymer damage on the surface of the catheter at the fractured distal tip.This damage may have occurred during retrieval from the patient.Further evaluation of the device revealed a kink proximal to the stretched location.This damage was likely due to the manipulation against resistance.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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left m1 segment of the middle cerebral artery (mca) using a penumbra system red 62 reperfusion catheter (red62), a bmx96 access system (bmx96), a stent retriever, and a guidewire.During the procedure, after completing the first pass using the red62 and the stent retriever, the physician removed both devices together from the patient.A fluoroscopy was performed and revealed that the distal end of the red62 was inside the patient.The physician used a penumbra system red72 reperfusion catheter (red72), a microcatheter, and a non-penumbra revascularization device to remove the distal end of the red62.The procedure ended at this point.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM RED 62 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: 20346296
• Report Number: 3005168196-2024-00332
• Device Sequence Number: 15459894
• Product Code: NRY
• UDI-Device Identifier: 00815948023536
• UDI-Public: 00815948023536
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K203440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2024
• 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 Catalogue Number: RED62SKIT
• Device Lot Number: H00005567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2024
• 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: 09/06/2024
• Initial Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2024
• 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: 58 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005