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

Model Number 12TLW405F35

Device Problem Break (1069)

Patient Problem Foreign Body Embolism (4439)

Event Date 02/27/2024

Event Type  Injury  

Manufacturer Narrative

The device will be returned for evaluation but has not yet arrived.Once it has arrived and the evaluation findings are available, a supplemental report will be submitted.The device history record review is pending.An engineering task has been assigned for further investigation.

Event Description

It was reported that there was a failure with a fogarty thru lumen embolectomy catheter, during use.The facility states the catheter split in the patient.The patient was transported to the hospital for removal.During thrombectomy, while using the catheter over the wire placed in the arterial direction, the fogarty balloon was passed over the arterial anastomosis, inflated, and pulled back into the patients graft.After a couple passes the doctor realized the balloon was not inflating under fluoro and pulled the catheter out of the sheath to inspect the balloon.While removing the catheter he realized the catheter had split in half and under fluoro you could visibly see the remainder of the catheter inside the patients graft.Retrieval forcep was used without success.The patient was transferred to the hospital for surgery for retrieval of the remaining catheter.The piece of the device that was surgically removed is not available for return.Location and type of graft, left upper arm graft.Percentage of graft occluded, 100 percent.Per the customer, it is the practice of this facility to use the fogarty thru lumen catheter versus the graft thrombectomy catheter to perform a thrombectomy of a graft vessel.Per the instructions for use, to remove fibrous or adherent material, alternative devices such as the fogarty corkscrew catheter and fogarty graft thrombectomy catheter are recommended.The physician did not experience resistance with the catheter passes prior to the catheter breaking apart.

Manufacturer Narrative

Per medical records provided by the facility, patient had history of end-stage renal disease, hypertension and was on dialysis.The patient was prepped for a left forearm thrombectomy of the loop graft that was clotted.The physician inserted the fogarty thru lumen catheter across the arterial anastomosis, which broke in half, leaving the balloon end of the catheter within the graft.The physician tried for 30 minutes to retrieve the broken piece of catheter out of the graft but was unable to remove it.The next day, after the patient was transferred to the hospital, the patient was taken to the or and an incision was made over the av graft and in the graft to visualize the remaining piece of catheter.The physician was able to remove the catheter piece with fluoroscopic guidance.The graft had no blood flow after the catheter piece was removed.A graft thrombectomy was then performed with a 4 french fogarty catheter which restored some blood flow to the graft.An arteriogram was then performed to assess the blood flow and it was determined that the graft was severely stenosed.A procedure was performed to dilate the arterial and venous anastomosis which restored good blood flow through the graft with no signs of clotting and there was a palpable thrill present.A product evaluation was performed by edwards lifesciences and it was found that an inspection of the device at the catheter body was broken at approximated 5cm distal of 20cm marker.Cross surface of broken section appeared uneven and rough.There was a broken piece from the catheter tip to the break location that was not returned from the facility.Per the instructions for use, 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.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.There was no other visible damage observed from catheter body.The device history record review was completed and all manufacturing inspections passed with no non conformances.An engineering evaluation has been initiated for further investigation.

Manufacturer Narrative

A supplemental mdr is being submitted as a engineering evaluation was initiated for any manufacturing related processes which could be correlated to the complaint.The instruction for use ifu states, 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.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.The thru-lumen embolectomy catheter is not recommended for the removal of fibrous, adherent, or calcified material.The catheter is not designed to withstand the additional pull force needed to remove these materials.Although the catheter body was confirmed to be broken during evaluation, there is no evidence that supports that the failure mode is associated with a manufacturing design defect.As part of the manufacturing process, 100 percent of the units are inspected.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 a part of the monthly review.

• Brand Name: FOGARTY THRU LUMEN EMBOLECTOMY CATHETER
• Type of Device: FOGARTY EMBOLECTOMY CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk km 1.4; anasco, puerto rico
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk km 1.4; anasco, puerto rico
• Manufacturer Contact: katheryn cespedes ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 18946494
• MDR Text Key: 338186576
• Report Number: 2015691-2024-02156
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00690103043488
• UDI-Public: (01)00690103043488(17)260108(11)231010(10)65314441
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K892410
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/21/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: 12TLW405F35
• Device Lot Number: 65314441
• 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: Not provided
• Initial Date FDA Received: 03/20/2024
• Supplement Dates Manufacturer Received: 03/04/2024; 05/06/2024
• Supplement Dates FDA Received: 03/28/2024; 05/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2023
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male