MAUDE Adverse Event Report: EDWARDS LIFESCIENCES IRVINE 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
Additional Manufacturer Narrative
Additional fda product code: kra: catheter, continuous flush.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.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 would not deflate.The doctor was filling it up with contrast and then when they tried to deflate it, it does not deflate.They will then dilute it and try to deflate it, and it will not go down.There was no allegation of patient injury.
Additional Manufacturer Narrative
The device was not returned therefore no evaluation could be performed since no objective evidence such as product samples, imagery, or videos was provided for investigation.As such, based on available information, a definite root cause is unable to be determined at this time.As part of the manufacturing process 100% of the units go through a full visual inspection process.A device history record review was completed and documented that the device met all specifications upon distribution.

• Brand Name: FOGARTY
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section G): EDWARDS LIFESCIENCES IRVINE; 1 edwards way; irvine CA 92614
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 20604360
• Report Number: 2015691-2024-08313
• Device Sequence Number: 12739989
• Product Code: DXE
• UDI-Device Identifier: 00690103043501
• UDI-Public: (01)00690103043501(17)261112(11)240813(10)65906518
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2024

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
• Operator of Device: Health Professional
• Device Model Number: 12TLW803F
• Device Lot Number: 65906518
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2024
• Supplement Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown