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

Model Number	12TLW803F
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our product evaluation lab received one model 12tlw803f catheter with an attached bd 1.0 ml syringe.The balloon was found to be ruptured and edges did not appear to match up.A 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.No visible damage or inconsistency was observed from catheter body and windings.The thru-lumen was patent without any leakage or occlusion.A device history record review was completed and documented that the device met all specifications upon distribution.The customer report of the balloon of the fogarty catheter ruptured was confirmed.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 or Problem Description
It was reported that the balloon of the fogarty, model 12tlw803f from lot 64394458, catheter ruptured during use.There were no patient complications reported.
Additional Manufacturer Narrative
Engineering evaluation was completed.A product risk assessment was needed.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 ARTERIAL 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: 16375992
• Report Number: 2015691-2023-10807
• Device Sequence Number: 6384950
• Product Code: DXE
• UDI-Device Identifier: 00690103043501
• UDI-Public: (01)00690103043501(17)240921(11)220623(10)64394458
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K892410
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2023

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: 09/21/2024
• Device Model Number: 12TLW803F
• Device Catalogue Number: 12TLW803F
• Device Lot Number: 64394458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2023
• Supplement Date Received by Manufacturer: 02/20/2023
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2022
• 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