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

Catalog Number RED72

Device Problems Fracture (1260); Leak/Splash (1354)

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

Event Date 03/05/2024

Event Type  malfunction  

Event Description

The patient was undergoing a thrombectomy procedure using penumbra system red 72 reperfusion catheters (red72) and sheath.During the procedure, the physician noticed that the first red72 appeared to be kinked.Therefore, the red72 was removed.While using a second red72, the physician noticed that the red72 was leaking.Upon removal, it was noticed that the red72 was fractured in the rotating hemostasis valve (rhv) of the sheath.The procedure was completed using a new red72.There was no report of an adverse effect to the patient.

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Manufacturer Narrative

Please note that the device associated with this complaint was expected to be returned; however, the device was lost in transit and is no longer available for return.Therefore, without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.H3 other text: placeholder.

• 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 ; 5107483200
• MDR Report Key: 19017366
• MDR Text Key: 340108168
• Report Number: 3005168196-2024-00119
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815948023925
• UDI-Public: 815948023925
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K211654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,05/04/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: RED72
• Device Lot Number: H00003739
• Was Device Available for Evaluation?: No
• 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
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 04/02/2024
• Supplement Dates Manufacturer Received: 04/05/2024
• Supplement Dates FDA Received: 05/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2023
• 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