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

Model Number	120805FP
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One fogarty catheter was received at our product evaluation laboratory for a full examination.As received, balloon was found to be ruptured at central area.Balloon edges did not appear to match at the ruptured region.No visible damage was found from catheter body and windings.Report of "balloon burst" was confirmed.Further evaluation was performed by the engineers in the manufacturing site.The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.As part of manufacturing process, the manufactured units go through a balloon inflation process.As per review of 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.Based on the available information there is no evidence that supports or confirms the failure mode being evaluated to be associated to a manufacturing/design defect.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, during procedure with this fogarty embolectomy catheter, the balloon burst.There is no allegation of patient injury.As per product evaluation findings, the balloon was found to be ruptured at central area and the edges did not appear to match at the ruptured region.

• Brand Name: FOGARTY EMBOLECTOMY CATHETER
• 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: 20038430
• Report Number: 2015691-2024-06339
• Device Sequence Number: 11563212
• Product Code: DXE
• UDI-Device Identifier: 00690103205220
• UDI-Public: (01)00690103205220(17)240522(11)220221(10)64231724
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K193379
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/22/2024

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: 05/22/2024
• Device Model Number: 120805FP
• Device Lot Number: 64231724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2022
• 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