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

Model Number	12TLW803F
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The fogarty embolectomy catheter was received for evaluation.During visual examination, balloon was found ruptured at the central area.The balloon edges did not appear to match at the ruptured region.Through lumen was patent without any leakage or occlusion.No other visible damage was observed from catheter body.The manufacturing records were reviewed for the lot involved and the product passed with a nonconformance reported on the dhr.Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing or design defect.As part of the device manufacturing the units go through a balloon inflation process.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 ".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.
Event or Problem Description
As reported, before use in patient, when inflating this fogarty catheter, the balloon burst.There was no allegation of patient injury.The device was received for evaluation and the balloon edges did not appear to match at the ruptured region.Patient demographics unable to be obtained.

• Brand Name: FOGARTY ARTERIAL EMBOLECTOMY CATHETER WITH GATE VALVE
• Common Device Name: 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: 19740264
• Report Number: 2015691-2024-05341
• Device Sequence Number: 7673906
• Product Code: DXE
• UDI-Device Identifier: 00690103043501
• UDI-Public: (01)00690103043501(17)250822(11)230524(10)65105742
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K233820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/15/2024

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: 08/22/2025
• Device Model Number: 12TLW803F
• Device Lot Number: 65105742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2023
• 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