MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER

Model Number 12TLW805F35

Device Problem Material Separation (1562)

Patient Problems Laceration(s) (1946); Foreign Body Embolism (4439)

Event Date 11/17/2022

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis but has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.A device history record review was completed and documented that the device met all specifications upon distribution.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.

Event Description

It was reported per medwatch mw5113478 that during a routine dialysis fistula declot, a fogarty model 12tlw805f35 catheter, lot 64545124 was used.The over the wire clot removal device has a small balloon on the tip of the catheter that allows you to inflate and push the clot out.The tip of this device broke away from the catheter and fell into a pseudoaneurysm of the fistula, requiring a covered stent to be placed over that area to lock in the object.The stent placement and additional efforts to retrieve the object were both successful.It was noted that the tip of the catheter had broken off and was lodged within a large pseudoaneurysm within the graft.At this point, the physician proceeded with stent graft across the pseudoaneurysm utilizing an 8 mm by 5 cm viabahn endograft.The skin overlying the pseudoaneurysm was then anesthetized with lidocaine, and a 1 cm incision was made utilizing a 15 blade.Utilizing fluoroscopy, the retained fogarty balloon fragment was removed in totality from the now excluded pseudoaneurysm.

Manufacturer Narrative

Our product lab received one model 12tlw805f35 catheter.As received, the catheter tip was completely broken at the distal end of the distal bushing and was not returned.The surface of the break appeared rough and uneven.Both bushings with the balloon were detached from the catheter.Adhesive was visible at the bond locations on the catheter tip.Per the ifu, balloon rupture and catheter separation as a result of excessive pull force applied to remove adherent material are the most frequent causes of reported failures.And, to minimize the risk of vessel damage, balloon rupture, or tip detachment, do not exceed the maximum recommended inflation and pull force for each size catheter.See specification table.No other visible damage or abnormality was observed from the rest of the catheter.The customer report of tip of this device broke was confirmed on evaluation.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.

• Brand Name: FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER
• Type of Device: FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER
• 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: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 15992419
• MDR Text Key: 306505244
• Report Number: 2015691-2022-10043
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00690103043532
• UDI-Public: (01)00690103043532(17)250102(11)221004(10)64545124
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K892410
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/07/2023

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: 64545124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 01/17/2023
• Supplement Dates FDA Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2022
• 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