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

Model Number	120602FP
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during prep of a model 120602fp fogarty catheter, the balloon was found to be defective.There was no patient involvement.The catheter came from lot number 63850952.The edwards sales representative spoke with the facilitys or director and was informed that they discovered the surgeon was over-inflating the balloons.The rep suggested an in service and further education was declined, as the other surgeons and or staff denied having any issues with fogarty balloon inflation.The suspect catheter was available for return.
Additional Manufacturer Narrative
The product evaluation lab received one model 120602f catheter for evaluation.As received, the spring tip was stretched.The balloon appeared to be pulled out from the proximal windings and was torn circumferentially at the distal windings.The torn latex was not returned.No other visible damage was observed from the catheter body.A device history record review was completed and documented that the device met all specifications upon distribution.The customer report of a defective balloon was confirmed on evaluation.An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing or design defect.As part of the manufacturing procedure, 100 percent balloon inspections are performed during the manufacturing process.Complaints incidence will continue to be monitored, and applicable actions will be taken as required.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.To minimize the risk of vessel damage, balloon rupture, or tip detachment, the maximum recommended inflation volume and pull force for the catheter should not be exceeded.See specification table.

• 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 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: 14239248
• Report Number: 2015691-2022-05447
• Device Sequence Number: 17254796
• Product Code: DXE
• UDI-Device Identifier: 50690103205201
• UDI-Public: (01)50690103205201(17)230929(11)210630(10)63850952
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/28/2022

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: 09/29/2023
• Device Model Number: 120602FP
• Device Lot Number: 63850952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 04/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2021
• 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