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

Model Number	120403FP
Medical Device Problem Codes	Material Fragmentation (1261); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our product evaluation lab received one model 120403fp catheter without any attached components.The balloon was found to be torn at the proximal, distal side and tip of the balloon latex.The proximal and distal side of the torn edges did not appear to match up.The balloon did not inflate due to leakage through the torn area.The balloon latex appeared deteriorated.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 visible damage was observed from both windings or the catheter body.The customer report of the balloon did not inflate was confirmed on evaluation.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.
Event or Problem Description
It was reported that prior to use of a model 120403fp fogarty embolectomy catheter, the balloon did not inflate when tested.A tear was noted on the balloon.There were no patient complications reported.The date of the event is unknown.
Additional Manufacturer Narrative
A device history record review was completed and documented that the device met all specifications upon distribution.An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.The root cause could not be associated to a manufacturing defect.As part of the manufacturing process controls, 100 percent of the units go through a balloon winding and visual inspection.In this inspection, the units are visually inspected to assess there are no bends, wrinkles, cuts, contamination, stains, deterioration, discoloration, or ripples.The instruction for use specifies the storage conditions for these catheters.A pra was previously generated to cover the balloons with fragmentations for embolectomy products.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.

• Brand Name: FOGARTY EMBOLECTOMY CATHETER
• Common Device Name: FOGARTY EMBOLECTOMY CATHETER
• 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: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 14879857
• Report Number: 2015691-2022-06467
• Device Sequence Number: 12027500
• Product Code: DXE
• UDI-Device Identifier: 00690103205084
• UDI-Public: (01)00690103205084(17)230121(11)201022(10)63292299
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMEN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2022

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: 01/21/2023
• Device Model Number: 120403FP
• Device Catalogue Number: 120403FP
• Device Lot Number: 63292299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2022
• Supplement Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2020
• 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