MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER; NRY

Model Number	RED68KIT-A
Medical Device Problem Codes	Break (1069); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in right middle cerebral artery (rmca) using a benchmark bmx96 access system (benchmark max), a penumbra system red 68 reperfusion catheter (red68), a non-penumbra microcatheter, a non-penumbra stent retriever device and a non-penumbra guidewire.During the procedure, the physician placed the benchmark max then advanced the red68 through the benchmark max.It was reported that the red68 would not advance past the ophthalmic artery.Therefore, the physician advanced the microcatheter and stent retriever device through the red68 and successfully completed five passes.After completing the last pass, the physician experienced resistance while retracting the red68.After few attempts to retract the red68 the physician pulled harder and heard a noise.Next, the physician removed the stent retriever device and the red68, then noticed the red68 to be fractured and stretched at approximately 110 cm from the hub.The procedure was completed at this point.Post angiography showed that no part of red68 was left inside the patient.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned red68 confirmed that the catheter was stretched and fractured.If the red68 is forcefully retracted against resistance, damage such as stretching and subsequent fracture may occur.The root cause of resistance during the procedure could not be determined.Penumbra catheters are visually 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 68 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: 13309042
• Report Number: 3005168196-2022-00018
• Device Sequence Number: 3284436
• Product Code: NRY
• UDI-Device Identifier: 00815948023895
• UDI-Public: 00815948023895
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K211411
• 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): 01/20/2022
• 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: 07/14/2024
• Device Model Number: RED68KIT-A
• Device Catalogue Number: RED68KIT
• Device Lot Number: H11576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• 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: 12/23/2021
• Initial Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2021
• 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: 43 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005