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

Model Number	120804F
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.However, an investigation will be initiated to assess for any manufacturing related processes which could be correlated to the lot number.A supplemental report will be forthcoming when the investigation is complete.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 during an axillary bifemoral bypass procedure the balloon became detached from a fogarty 4fr model 120804f catheter and was retained in the patient.The procedure was completed with a new fogarty catheter.Per the customer, it was determined that no additional procedure was performed based on risk to the patient.There was no allegation of patient injury.The device is not available for return.
Additional Manufacturer Narrative
The device was not returned for evaluation as the hospital discarded the device.The customer report of balloon detached, separated was unable to be confirmed through product evaluation code since the affected unit was not returned for evaluation; therefore a product non-conformance or device failure could not be confirmed.No corrective action is not required at this time.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.The ifu contains the following warnings: balloon rupture and catheter separation as a result of excessive pull force applied to remove adherent material are the most frequent causes of reported failures.The possibility of balloon rupture must be taken into account when considering the risks involved in any embolectomy procedure.To minimize the risk of vessel damage, balloon rupture, or tip detachment, do not exceed the maximum recommended inflation volume and pull force for each size catheter.Use of a highly viscous or particulate contrast medium is not recommended for balloon inflation because the inflation lumen may become occluded.To avoid air embolus in case of balloon rupture, air should not be used for balloon inflation.Carbon dioxide is the only recommended gas.As part of the manufacturing process a 100% of the units go through a balloon winding and full visual inspection process.A device history record review was completed and documented that device met all specifications upon distribution.

• 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
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 19635784
• Report Number: 2015691-2024-04972
• Device Sequence Number: 18341238
• Product Code: DXE
• UDI-Device Identifier: 00690103043303
• UDI-Public: (01)00690103043303(17)260305(11)231205(10)65443859
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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): 07/26/2024

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: 03/05/2026
• Device Model Number: 120804F
• Device Lot Number: 65443859
• 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: 06/11/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/05/2023
• 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