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

Model Number	12TLW405F35
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product evaluation was completed.The reported event of balloon deflation issue was confirmed.The balloon latex and both windings appeared to be in good condition.The balloon was inflated with 1.7 cc air and the balloon inflated clear and concentric for 5 min.There is no deflation spec.Using air as the inflation media.The balloon was again inflated using 0.9 cc water and the balloon inflated clear and concentric, however, resistance was felt.Balloon deflation was achieved in 37 sec by pulling back on the syringe plunger.The max.Deflation time from full capacity is 15 sec while pulling back on the syringe plunger.The through lumen was patent without any leakage or occlusion.A supplemental report will be forthcoming when the investigation is 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.
Event or Problem Description
It was reported that the balloon of a fogarty catheter had deflation difficulties.Per follow up with rep, no information was available on whether the balloon was eventually able to be deflated.No additional incision was required to remove the catheter.Patient demographics were requested but unavailable.There were no patient complications reported.
Additional Manufacturer Narrative
An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.Based on the available information, the failure is associated to a manufacturing defect.A product risk assessment was initiated to address balloon deflation issues and a capa was generated to investigate and perform actions regarding the deflation balloon issue.A device history record review was completed and documented that device met all specifications upon distribution.
Additional Manufacturer Narrative
Further product investigation was completed.Cut down was performed on the catheter body to locate occlusion.Balloon inflation lumen was found to be collapsed near the proximal windings.

• Brand Name: FOGARTY THRU LUMEN EMBOLECTOMY CATHETER
• 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: jonathan diaz ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 18913143
• Report Number: 2015691-2024-02045
• Device Sequence Number: 7042396
• Product Code: DXE
• UDI-Device Identifier: 00690103043488
• UDI-Public: (01)00690103043488(17)251126(11)230828(10)65116225
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/25/2024

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
• Device Expiration Date: 11/26/2025
• Device Model Number: 12TLW405F35
• Device Lot Number: 65116225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2024
• 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: 02/28/2024
• Supplement Date Received by Manufacturer: 04/16/2024; 04/09/2024
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 04/18/2024; 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2023
• 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