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

Catalog Number	RED62S
Medical Device Problem Codes	Stretched (1601); Unraveled Material (1664); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left distal internal carotid artery (ica) using a penumbra system red 62 reperfusion catheter (red62), a neuron max 6f 088 long sheath (neuron max), a non-penumbra microcatheter, and guidewires.It should be noted that the patient's anatomy was tortuous.During the procedure, the physician experienced resistance while advancing the red62 together with the microcatheter and the guidewire through the distal end of the neuron max during the second pass.The physician then removed the devices, flushed the red62 in a saline solution, and attempted to re-advance the red62, microcatheter, and guidewire together through the neuron max.While re-advancing the devices through the neuron max, the physician experienced resistance.The physician then decided to remove the red62 and experienced resistance retracting the devices through the neuron max.The physician continued removing the devices and, after removal of the red62, the physician found that the distal length of the red62 was stretched and unraveled.The procedure was completed using the same neuron max and a stent retriever.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Additional Manufacturer Narrative
The device was returned for analysis and has been evaluated.Evaluation of the returned red62 confirmed that the catheter was stretched and fractured on its distal shaft, and the support coil winds were unraveled at the fractured locations.This damage typically occurs due to retraction against resistance.If the red62 is retracted against resistance, it may become stretched and subsequently fracture.The fractured distal segment was not returned for evaluation.It was reported that the patient¿s anatomy was tortuous.This likely contributed to the resistance during the procedure.Further evaluation of the returned red62 revealed that the strain relief was stretched on its distal end, and the catheter had ovalizations on the catheter shaft.This damage was incidental to the reported complaint and 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: 19099348
• Report Number: 3005168196-2024-00137
• Device Sequence Number: 7343529
• Product Code: NRY
• UDI-Device Identifier: 00815948023475
• UDI-Public: 815948023475
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K203440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2024
• 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: 06/21/2026
• Device Catalogue Number: RED62S
• Device Lot Number: F00007272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/21/2024
• Supplement Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 06/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2023
• 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 Age: 59 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005