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

Model Number 120404FP

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

The device is anticipated to be returned for evaluation but has not yet been received.A supplemental will be sent with the evaluation results, as well as the device history record review results when completed.

Event Description

It was reported that a balloon tip broke off an embolectomy catheter.There was no allegation of patient injury.Attempts were made for further details of event.However, no additional information was provided by customer.

Manufacturer Narrative

The device was not returned for evaluation.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.No corrective actions will be taken at this time.Corrections to the h6 codes type of investigation, investigation findings, and investigation conclusions were made.A device history record review was completed and documented that the device met all specifications upon distribution.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.

• Brand Name: FOGARTY ARTERIAL EMBOLECTOMY CATHETER
• Type of Device: 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: katheryn richards ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 18387122
• MDR Text Key: 331492731
• Report Number: 2015691-2023-18696
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 50690103205102
• UDI-Public: (01)50690103205102(17)240821(11)220523(10)64367856
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/07/2024

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 Operator: Health Professional
• Device Model Number: 120404FP
• Device Lot Number: 64367856
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 02/07/2024
• Supplement Dates FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2022
• 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