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

Model Number	120803FP
Medical Device Problem Codes	Material Fragmentation (1261); Material Rupture (1546)
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 120803f embolectomy catheter.The balloon was found to be ruptured between the windings.The latex edges did not appear to match at the ruptured region.Per the ifu, 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.And to minimize the risk of vessel damage, balloon rupture, or tip detachment, do not exceed the maximum recommended inflation and pull force for each size catheter.See specification table.No other visible damage was observed from the catheter body and windings.The through lumen was patent without any leakage or occlusion.A device history record review was completed and documented that the device met all specifications upon distribution.The customer report of a balloon issue was confirmed on evaluation.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Complaint histories for all reported events are reviewed against trending control limits and any excursions above the control limits are assessed and documented as part of this monthly review.
Event or Problem Description
It was reported that prior to use, the balloons on seven arterial embolectomy catheters were noted to have holes in them when inflated.It was stated that the surgeon was concerned and has a bunch of experience with these catheters, so the customer felt that it was not user error.The only troubleshooting was to get another catheter however, the tech stated that as she inflated the balloon with fluid there were multiple pin holes in the balloon.There was no patient injury.The exact date of the event is unknown.This report is for one model 120803fp catheter from lot 63954397.
Additional Manufacturer Narrative
An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.A product risk assessment addresses balloons with fragmentations for embolectomy catheters.As part of the manufacturing process controls, 100 percent of the units go through a balloon and winding inspection.

• Brand Name: FOGARTY ARTERIAL 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: 15321025
• Report Number: 2015691-2022-07607
• Device Sequence Number: 14829200
• Product Code: DXE
• UDI-Device Identifier: 00690103205091
• UDI-Public: (01)00690103205091(17)231209(11)210909(10)63954397
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2022

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: 12/09/2023
• Device Model Number: 120803FP
• Device Catalogue Number: 120803FP
• Device Lot Number: 63954397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2022
• Supplement Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2021
• 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