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

Catalog Number	RED62SKIT
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned red62 confirmed that the catheter was fractured.If the red62 is retracted against resistance, damage such as a fracture may occur.Based on the reported event, the root cause of resistance could not be determined.Further evaluation revealed that the support coil winds of the red62 was wrapped around the delivery wire of the non-penumbra stent.This damage was incidental to the reported complaint and likely occurred during retraction of the device upon removal from the patient.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 m1 segment of the middle cerebral artery (mca) using a penumbra system red 62 reperfusion catheter (red62) and a penumbra system red 43 reperfusion catheter (red43).During the procedure, the physician completed three passes in the target vessel using the red62.While retracting the red62, the physician experienced resistance.Upon removal of the red62, the physician noticed that the distal length of the red62 was unraveled.The physician then attempted to remove the thrombus with the red43, however, the occlusion could not be removed.The procedure was completed at this point after achieving thrombolysis in cerebral infarction (tici) score of 2a.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: 19392741
• Report Number: 3005168196-2024-00206
• Device Sequence Number: 7799970
• Product Code: NRY
• UDI-Device Identifier: 00815948023536
• UDI-Public: 815948023536
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/24/2024
• 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: F00010257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2024
• 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: 04/29/2024
• Initial Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2024
• 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: 66 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/01/2005