MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER; CATHETER, EMBOLECTOMY

Model Number 12TLW805F35

Device Problem Device Damaged Prior to Use (2284)

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

Event Type  malfunction  

Manufacturer Narrative

One 12tlw805f35 fogarty embolectomy catheter with attached bd 3ml syringe was returned for evaluation.The customers report of balloon leakage was confirmed.The balloon inflated but did not maintain its inflation due to leakage from through lumen port.Visual examination found a crack inside of catheter tip.The size of the crack could not be measured because it was inside of the lumen.The crack did not reach the surface of the catheter tip.The edges of cracks did not appear to match up.When air was injected into the through lumen while covering the through lumen port for a leak test, the balloon inflated but no other leakage was observed.There were no visible damages observed from the balloon and windings.An engineering evaluation was assigned to the manufacturing site for further investigation.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.

Event Description

It was reported that before use, balloon leakage was observed, and the balloon would not inflate.There were no patient complications reported.The product was returned for evaluation.Visual examination found a crack inside of the catheter tip.The edges of cracks did not appear to match up.

Manufacturer Narrative

A device history record review was completed and documented that device met all specifications upon distribution.Engineering eval completed.A capa was initiated for this issue and a product risk assessment was needed.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.

• Brand Name: FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 15008467
• MDR Text Key: 304600156
• Report Number: 2015691-2022-06759
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K892410
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/09/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2024
• Device Model Number: 12TLW805F35
• Device Catalogue Number: 12TLW805F35
• Device Lot Number: 64036596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/27/2022
• Initial Date FDA Received: 07/13/2022
• Supplement Dates Manufacturer Received: 07/20/2022
• Supplement Dates FDA Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2021
• 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