MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR FOGARTY ARTERIAL EMBOLECTOMY CATHETER; CATHETER, EMBOLECTOMY

Model Number 12TLW403F

Device Problems Burst Container or Vessel (1074); Material Rupture (1546)

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

Event Date 02/28/2023

Event Type  malfunction  

Manufacturer Narrative

The fogarty catheter was received by our product evaluation laboratory for a full evaluation.Customer report of balloon burst was confirmed.The balloon was found to be ruptured in the middle area and the rupture edges did not appeared to match up.Through lumen was patent without any leakage or occlusion.No other visible damage or abnormality was observed from catheter body or windings.Engineering evaluation will be completed to consider any potential factors that may have contributed to this complaint and 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.

Event Description

As reported, while testing this fogarty catheter, the balloon burst.There was no allegation of patient injury.The device was received for evaluation and balloon rupture edges did not appear to match up.

Manufacturer Narrative

Added: d4 (expiration date), h4 (device manufacturer date) updated: h6 (device code, type of investigation, investigation findings, investigation results).Evaluation results revealed that the reported event of balloon burst was confirmed.Further investigation was completed by the engineers in the manufacturing site and based on the available information, it could not be determined that the failure is related to a manufacturing or design defect.The manufacturing records were reviewed and there is no indication of a related nonconformance; all process parameters were met and inspections passed successfully.Additionally, it could be verified that as part of the catheter manufacturing process, the units go through a balloon inflation and winding inspection.Based on this assessment, no further action is required at this time.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.

• Brand Name: FOGARTY ARTERIAL EMBOLECTOMY CATHETER
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco, puerto rico
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 16591486
• MDR Text Key: 311825452
• Report Number: 2015691-2023-11764
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193379
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/22/2023

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: 12TLW403F
• Device Catalogue Number: 12TLW403F
• Device Lot Number: 64368199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/28/2023
• Initial Date FDA Received: 03/22/2023
• Supplement Dates Manufacturer Received: 05/15/2023
• Supplement Dates FDA Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2022
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 75 KG