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

Model Number	12TLW803F
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our product evaluation lab received one model 12tlw803f catheter with attached bd 1.0 ml syringe.A guidewire was inserted into thru-lumen from hub to 34.5 cm proximal from the tip.The gate valve was able to be opened and closed without resistance.No visible damage was observed from the gate valve.The balloon was found to be ruptured.After cutting distal windings, the ruptured edges did not appear to match up.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.To minimize the risk of vessel damage, balloon rupture, or tip detachment, do not exceed the maximum recommended inflation volume and pull force for each size catheter.As received, the thru-lumen was occluded with blood at 5 cm proximal from tip.To remove the blood, the catheter was cut at 20 cm proximal from the tip.With hot water and lab stylet wire, the blood was removed.Thru-lumen of the catheter was tested for the patency with lab 0.018 inch and returned guidewire and the guidewires could pass through tip to proximal or proximal to tip with both catheter parts.No other visible damage or inconsistency was observed from catheter body and windings.A device history record review was completed and documented that the device met all specifications upon distribution.The customer report of the gate valve became unable to be opened and the guidewire did not pass through the catheter, were unable to be confirmed.An engineering evaluation was completed, and product risk assessment was generated earlier which addressed the balloon with fragmentation failures for thru-lumen products.No corrective action was required.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 or Problem Description
It was reported that two problems occurred in the same 12tlw803f fogarty catheter during use.The gate valve became unable to be opened and the guidewire did not pass through the catheter.These issues were resolved by replacing the catheter with a new one.There were no patient complications reported.

• Brand Name: FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER
• Common Device Name: FOGARTY THRU-LUMEN
• 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: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492507258
• MDR Report Key: 16914784
• Report Number: 2015691-2023-12933
• Device Sequence Number: 6355901
• Product Code: DXE
• UDI-Device Identifier: 00690103043501
• UDI-Public: (01)00690103043501(17)240322(11)211222(10)64124872
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K892410
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/11/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/22/2024
• Device Model Number: 12TLW803F
• Device Catalogue Number: 12TLW803F
• Device Lot Number: 64124872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown