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

Model Number 12TLW803F

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

One fogarty embolectomy catheter with attached bd 1.0 ml syringe was returned for evaluation.Balloon was found to be ruptured and the ruptured edges were not able to match up.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 visible damage or inconsistency to both windings, catheter body, or returned syringe was observed.Through lumen was patent without any leakage or occlusion.Visual examination was performed under microscope at 20x magnification and with the unaided eyes.A device history record review was completed and documented that device met all specifications upon distribution.Customer report of balloon rupture issue was confirmed.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.The fogarty thru-lumen embolectomy catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.The thru-lumen embolectomy catheter is not recommended for the removal of fibrous, adherent or calcified material such as chronic clot or atherosclerotic plaque.The catheter is not designed to withstand the additional pull force needed to remove these materials.The ifu for the product contains the following warning: 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.The possibility of balloon rupture must be taken into account when considering the risks involved in any embolectomy procedure.To minimize the risk of vessel damage, balloon rupture, or tip detachment, do not exceed the maximum recommended inflation volume and pull force for each size catheter.It is not known if user or procedural factors played a role in the stated event.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.

Event Description

It was reported that the balloon of the fogarty thru-lumen embolectomy catheter ruptured at the balloon test prior to use.Patient demographic information requested but not available.There were no patient complications reported.

• 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, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500249
• MDR Report Key: 11164605
• MDR Text Key: 226638240
• Report Number: 2015691-2021-00148
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K892410
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/02/2020

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: 11/25/2021
• Device Model Number: 12TLW803F
• Device Catalogue Number: 12TLW803F
• Device Lot Number: 62505428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 01/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2019
• 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