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

Model Number 12TLW805F35

Device Problem Deflation Problem (1149)

Patient Problem Vascular Dissection (3160)

Event Date 03/10/2023

Event Type  Injury  

Event Description

As reported, during use in patient with this fogarty catheter, the balloon couldn't be deflated after removing part of the thrombus.Thus, the vascular incision was enlarged to remove the catheter.The balloon couldn't be deflated when tried outside patient's body.The procedure was completed by replacing with a new unit.There was no allegation of patient injury.The device was available for evaluation.Patient demographics requested and unable to be obtained.

Manufacturer Narrative

The device was received at the product evaluation laboratory for a full evaluation and to consider any potential factors that may have contributed to this complaint.Upon the investigation will be completed, a supplemental report will be sent with the investigation results.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Manufacturer Narrative

Added: h6 (type of investigation).Updated: h3 (device evaluated by manufacturer), h6 (investigation findings, investigation conclusions).Further investigation was completed by the engineers in the manufacturing site, and it could be concluded that the failure is likely due to manufacturing.The manufacturing personnel has been notified about this condition and this non-conformity is currently being investigated to prevent recurrence of this type of complaint.There is no sufficient evidence that more affected units were distributed in the market with the same condition.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 involved in this case was received at our product evaluation laboratory for evaluation.Report of "balloon couldn't be deflated" was confirmed.The balloon was inflated with 0.9 milliliters ro water and the balloon inflated concentric and did not leak.However, balloon could not deflate completely after 60 seconds (aided with water).The maximum deflation time is 15 seconds (aided with water).Balloon deflation time with water was out of specification.Then, cut down was performed on the catheter body to locate occlusion.Balloon inflation lumen was found to be collapsed near the proximal bushing.Balloon latex, bushings and windings were intact.Through lumen was patent without any leakage or occlusion.No visible damage was observed from catheter body.

• 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 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: 16712901
• MDR Text Key: 313038710
• Report Number: 2015691-2023-12229
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 12TLW805F35
• Device Catalogue Number: 12TLW805F35
• Device Lot Number: 64664592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/17/2023
• Initial Date FDA Received: 04/11/2023
• Supplement Dates Manufacturer Received: 05/09/2023; 06/13/2023
• Supplement Dates FDA Received: 06/06/2023; 06/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2022
• 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 Outcome(s): Required Intervention; Other