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

Model Number	120404FP
Medical Device Problem Codes	Burst Container or Vessel (1074); Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The fogarty arterial embolectomy catheter involved in this case was received by our product evaluation laboratory for evaluation.As received, the balloon latex appeared deteriorated.Multiple cracks and ruptures were evident on balloon latex.Balloon edges did not appear to match up at the ruptured regions.Per internal specification, latex deterioration is "a condition usually caused by age, excessive exposure to light, atmosphere, or ozone.Appears on the balloon surface as a maze of fine cracks or crazing.The condition may occur in a small area or cover the entire balloon".No other visible damage was observed from catheter body.The manufacturing records were reviewed and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.The storage conditions for these catheters are specified in the ifu.A product risk assessment addresses balloons with fragmentations for embolectomy catheters, and a capa to address this issue has been implemented.The capa investigation concluded that the root cause is exposure of latex to ozone, which can happen when the pouch packaged device is stored in rooms with high energy ionizing radiation sources that could generate ozone e.G.Fluoroscopy machines, x ray machines, uv lights, hvac sanitation equipment, etc.As a result, fca 90905 was voluntarily initiated instructing customers to return any product which has been stored in the same room as high energy ionizing radiation sources which emit ozone.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 part of this monthly review.
Event or Problem Description
As reported, while testing before use in patient, the balloon of this fogarty arterial embolectomy catheter burst.There was no allegation of patient injury.The catheter was received for evaluation and the balloon latex appeared deteriorated.Multiple cracks and ruptures evident on the balloon latex and the balloon edges did not appear to match up at the ruptured regions.
Additional Manufacturer Narrative
Updated section h6 (impact code), h6 (investigation findings) and h6 (investigations conclusions).Based on further review of the event a root cause related to user error has been identified since the product was expired at the time it was used.The manufacturing date of the finished good product is 02/28/22 with an expiration date of 05/29/24.The date of the event was on 09/19/24.

• Brand Name: FOGARTY ARTERIAL EMBOLECTOMY CATHETER
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 21708112
• Report Number: 2015691-2025-02295
• Device Sequence Number: 4745627
• Product Code: DXE
• UDI-Device Identifier: 00690103205107
• UDI-Public: (01)00690103205107(17)240529(11)220228(10)64269069
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193379
• 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: Other
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2025

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: 05/29/2024
• Device Model Number: 120404FP
• Device Lot Number: 64269069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2022
• 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