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

Model Number	140806
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the latex membrane got torn after several (3-4 times) actuation during use.No patient injury was reported.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.
Additional Manufacturer Narrative
Our product evaluation lab received one model 140806 adherent clot catheter without any attached components.The customer report of the latex membrane got torn was confirmed.As received, a tear was observed on latex membrane.The tear size was approximately 1 mm x 1 mm.After cutting the proximal and distal membrane bonding site, the edges of the tear appeared to match up.Per edwards ifu, exposure to the atmosphere, handling during insertion, and plaque and other deposits within the blood vessel may cause latex membrane degradation.And to minimize the risk of vessel or membrane damage, do not exceed the maximum recommended pull force.No visible damage was observed from catheter body.Both the core wire and the thumb slide on the handle were functional.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.The customer report of broken catheter was confirmed with objective evidence through the product evaluation.Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing/ design defect.As part of the manufacturing process, 100% of units go through visual inspection to verify general appearance, contamination, length of the tube, diameter of the bonding and spiral coil verification in closed position.Also, a 100% inspection of the functionality of the handler is performed activating it 3 consecutive times to verify the behavior of the coils, spiral and latex membrane integrity.A device history record review was completed and documented that device met all specifications upon distribution.

• Brand Name: FOGARTY ARTERIAL EMBOLECTOMY II 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: 19337284
• Report Number: 2015691-2024-03659
• Device Sequence Number: 16786319
• Product Code: DXE
• UDI-Device Identifier: 00690103042412
• UDI-Public: (01)00690103042412(17)250612(11)230314(10)64924231
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K901625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2024

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 Expiration Date: 06/12/2025
• Device Model Number: 140806
• Device Lot Number: 64924231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/29/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2023
• 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