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

Model Number	12TLW403F
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A report is being submitted for this returned 12tlw403f fogarty catheter due to evaluation findings.Customer report of balloon rupture was confirmed.As received, balloon was found to be ruptured in the central area.Balloon edges did not match at the ruptured region.The ruptured part was not returned.Both balloon windings were intact.No other visible damage was observed from the catheter.The lot history review was performed for lot number 65432258 (in 630463058) and one additional complaint with the same lot number and defect code was evaluated related to this nonconformance for thru lumen product models.The balloon lots used (65154685 and 65150987) in the last 12 months complaints units were evaluated but no information could be associated to the balloon failure related to this nonconformance for thru lumen product models.As part of the manufacturing process 100% of the units go through balloon and winding inspection process.Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing/design defect.The ifu indicates: warnings such as, 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.The possibility of balloon rupture must be taken into account when considering the risks involved in any embolectomy procedure.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.See specification table.To avoid air embolus in case of balloon rupture, air should not be used for balloon inflation, and that carbon dioxide is the only recommended gas.
Event or Problem Description
It was reported that the balloon of the 12tlw403f fogarty catheter ruptured before use.Patient demographics were requested but unavailable.There were no patient complications reported.

• Brand Name: FOGARTY
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco 00610 ; * 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco 00610 ; * 00610
• Manufacturer Contact: erika bonilla ; one edwards way; irvine, CA 92614
• MDR Report Key: 20879562
• Report Number: 2015691-2024-09374
• Device Sequence Number: 8956106
• Product Code: DXE
• UDI-Device Identifier: 00690103043457
• UDI-Public: (01)00690103043457(17)260430(11)240130(10)65432258
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K240078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/09/2024

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: 04/30/2026
• Device Model Number: 12TLW403F
• Device Lot Number: 65432258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2024
• 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: 11/18/2024
• Initial Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2024
• 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