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

Model Number 120804FP

Device Problems Inflation Problem (1310); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that during a procedure, a model 120804fp fogarty catheter balloon failed to inflate.There was no reported patient injury and demographics were not provided.The date of the event was unknown.

Manufacturer Narrative

Our product evaluation laboratory received one model 120804f catheter for evaluation.The balloon appeared to have deteriorated, and the balloon latex had multiple tears and cracks.Leakage was observed through multiple tears.The proximal windings were removed to match the balloon edges.The balloon edges did not appear to match at the location of the leak.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.Both balloon windings were intact.No other visible damage was observed from the catheter body.A device history record review has been initiated and a supplemental report will be sent with the investigation results.The customer report of "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.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.

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 already 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
• Type of Device: 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: 14940171
• MDR Text Key: 302116386
• Report Number: 2015691-2022-06645
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00690103205213
• UDI-Public: (01)00690103205213(17)230614(11)210315(10)63669975
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMEN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2023
• Device Model Number: 120804FP
• Device Catalogue Number: 120804FP
• Device Lot Number: 63669975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1