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

Model Number	12TLW803F
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported during testing before use in a patient the balloon of this fogarty catheter could not be deflated.There was no allegation of patient injury.The device will be available for evaluation.
Additional Manufacturer Narrative
The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming when the investigation is completed.The device history record review has not yet been completed.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 a part of the monthly review.
Additional Manufacturer Narrative
One fogarty catheter was returned for evaluation.Customer report of could not be deflated was unable to be confirmed.The balloon and windings were examined and appeared to be in good condition without any damage or abnormality.The balloon was inflated with 0.4 ml air and 0.15 ml water as recommended in the product ifu.The balloon inflated clear and concentric and remained inflated for 5 minutes without leakage.Balloon deflation was achieved in 4 sec by pulling back on the syringe plunger as recommended in product ifu.Maximum deflation time from full capacity is 15 seconds per product ifu.The through lumen was found to be patent and did not leak.No visible damage or abnormality was observed from the catheter body or returned syringe.The device history record review was completed and the product passed without any nonconformances.As part of the manufacturing process, 100% of units are inspected according to drawing specifications, the balloon is visually inspected, and for inflation and deflation, the catheter is inspected for obstruction or restricted tube, for hub / shrink leakage and for bushings and tip leakage.Furthermore, a deflation test to the balloons is performed after filled with water through a syringe.As per procedure, balloon free deflation time requirements are established for all models.An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.The complaint affected product was returned for evaluation and no defect was found; therefore, a product non-conformance or device failure associated to manufacturing or design could not be confirmed and a root cause could not be established.

• Brand Name: FOGARTY
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: samantha eveleigh ; 17200 laguna canyon rd; irvine, CA 92618 ; 9492017706
• MDR Report Key: 23830353
• Report Number: 2015691-2025-10280
• Device Sequence Number: 13000455
• Product Code: DXE
• UDI-Device Identifier: 00690103043501
• UDI-Public: (01)00690103043501(17)270821(11)250522(10)66489735
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K240078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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 Model Number: 12TLW803F
• Device Lot Number: 66489735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/26/2025
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2025
• 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