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

Model Number 12TLW405F35

Device Problem Deflation Problem (1149)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/29/2024

Event Type  malfunction  

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 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.

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.

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
• Type of Device: 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: jonathan diaz ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 18913143
• MDR Text Key: 337769753
• Report Number: 2015691-2024-02045
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00690103043488
• UDI-Public: (01)00690103043488(17)251126(11)230828(10)65116225
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K892410
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1