MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR FOGARTY OCCLUSION CATHETER; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Model Number 62080822F

Device Problem Material Rupture (1546)

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

Event Date 05/30/2023

Event Type  malfunction  

Event Description

As reported, during an organ extraction procedure under protocol maastricht iii.The balloon of this fogarty occlusion catheter burst.The issue was noticed since the patient's upper body was supposed to be in total ischemia.And it was observed, revascularization of the patient's upper body.The balloon burst was observed as per radiological inspection.The device was replaced with a device from the same batch in order to complete the procedure.The catheters were inserted via the extracorporeal circulation(cec), with an endoreturn edwards 21f cannula.There were no consequences.The device is available for evaluation.

Manufacturer Narrative

The product is expected to be returned for analysis.However, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis.And any excursions above the control limits are assessed and documented as part of this monthly review.

Manufacturer Narrative

The fogarty catheter was received at our product evaluation laboratory for a full evaluation.As received, balloon was ruptured in the central area.The edges of ruptured latex appeared to match.Customer report of "balloon burst" was confirmed.Per the instructions for use "to minimize the risk of vessel damage, balloon rupture, or tip detachment, do not exceed the maximum recommended inflation volume for each size catheter.Exposure to calcified plaque within the vessel may increase the possibility of balloon rupture." both balloon windings were intact.No other visible damage was observed from catheter.The manufacturing records were reviewed and there is no indication of a related nonconformance; all process parameters were met and inspections passed successfully.

• Brand Name: FOGARTY OCCLUSION CATHETER
• Type of Device: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 17287288
• MDR Text Key: 318924434
• Report Number: 2015691-2023-14469
• Device Sequence Number: 1
• Product Code: MJN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 08/17/2023

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 Model Number: 62080822F
• Device Catalogue Number: 62080822F
• Device Lot Number: 64835351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/20/2023
• Initial Date FDA Received: 07/10/2023
• Supplement Dates Manufacturer Received: 07/21/2023
• Supplement Dates FDA Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2023
• 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