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

Catalog Number	RED62SKIT
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
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.H3 other text : placeholder.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m1 segment of middle cerebral artery (mca) the using a penumbra system red 62 reperfusion catheter (red62), a velocity delivery microcatheter (velocity), a stent retriever.It was noted that the patient''s anatomy was tortuous.During the procedure, the physician completed one pass with the red62.After taking an image, the physician advanced a stent retriever to the target vessel and completed a second pass.After retracting the stent retriever through the red62, the physician noticed that the red62 was leaking from proximal end of the red62, near the hub.The procedure ended at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned red62 confirmed that the catheter leaked near the hub underneath the strain relief.During evaluation, the red62 was flushed, and a leak was observed coming from underneath the strain relief.Evaluation revealed a kink under the strain relief.If the proximal end of the red62 is handled at an angle during use, damage such as a kink may occur.This damage may have contributed to the reported leak during the procedure.Further evaluation of the red62 revealed additional kinks and ovalization on the catheter shaft.Based on the reported event, this damage was incidental to the complaint.The ovalization likely occurred during removal of the red62 from the patient¿s body and the kinks likely occurred during packaging for return to penumbra.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 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: 19235339
• Report Number: 3005168196-2024-00168
• Device Sequence Number: 8072519
• Product Code: NRY
• UDI-Device Identifier: 00815948023536
• UDI-Public: 815948023536
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 05/29/2024
• 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: 08/27/2026
• Device Catalogue Number: RED62SKIT
• Device Lot Number: F00008226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2024
• 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: 04/12/2024
• Supplement Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 05/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2023
• 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 Sex: Female
• Date Report Sent to FDA: 01/01/2005