MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER; NRY

Model Number RED72KIT-A

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/24/2022

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the returned red72 revealed that the marker band was damaged at the distal tip of the catheter.This is likely the reported distal end fracture.If the red72 is inadvertently manipulated against resistance, damage such as this may occur.Further evaluation revealed multiple kinks throughout the length of the catheter.This damage was incidental to the reported complaint and likely occurred due to manipulation against resistance.The red72 was unable to be advanced through a demonstration neuron max during testing.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 Description

The patient was undergoing a thrombectomy procedure in the right internal carotid artery (ica) using a penumbra system red 72 reperfusion catheter (red72), neuron max 6f 088 long sheath (neuron max) and a penumbra system 3max reperfusion catheter (3maxc).During the procedure, the physician experienced resistance and had difficulty tracking the red72 while performing the first pass.However, the physician was able to complete the first pass.Upon removal, the physician noticed that the distal end of the red72 was fractured.The procedure was completed using a red62 and the same neuron max.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 510748-320
• MDR Report Key: 13840658
• MDR Text Key: 288806691
• Report Number: 3005168196-2022-00132
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815948023932
• UDI-Public: 00815948023932
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RED72KIT-A
• Device Catalogue Number: RED72KIT
• Device Lot Number: F108924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Female