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

Model Number 12TLW805F35

Device Problems Burst Container or Vessel (1074); Degraded (1153); Material Rupture (1546)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 10/23/2019

Event Type  malfunction  

Manufacturer Narrative

Our product evaluation laboratory received one model 12tlw805f35 catheter.The balloon appeared deteriorated, as a maze of cracks and discoloration were visible on the balloon latex and leakage was noticed through the cracks and holes in the balloon latex.The balloon latex edges at the deteriorated area did not appear to match up.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.".The through lumens were patent without any leakage or occlusion.No 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 report of a balloon issue was confirmed on evaluation due to latex deterioration.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.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.The thru-lumen embolectomy catheter is not recommended for the removal of fibrous, adherent, or calcified material (e.G.Chronic clot, atherosclerotic plaque).This catheter is not designed to withstand the additional pull force needed to remove these materials.The instructions for use of the product contains the following statement: ¿as with all catheterization procedures, complications may occur.These may include local or systemic infection, local hematomas, intimal disruption, arterial dissection, perforation and vessel rupture, hemorrhage, arterial thrombosis, distal embolization of blood clots and atherosclerotic plaque, air embolus, aneurysm, arterial spasm, arteriovenous fistula formation, and balloon rupture with fragmentation, tip separation and distal embolization.¿ 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 prior to use, the balloon on a fogarty catheter burst when tested.There was no allegation of patient injury.Demographics were requested and not provided.

Manufacturer Narrative

Reference capa-20-00141.

• 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
• MDR Report Key: 9321917
• MDR Text Key: 196932889
• Report Number: 2015691-2019-04221
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• PMA/PMN Number: K892410
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/24/2019

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: 04/29/2021
• Device Model Number: 12TLW805F35
• Device Catalogue Number: 12TLW805F35
• Device Lot Number: 61825718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Initial Date Manufacturer Received: 10/24/2019
• Initial Date FDA Received: 11/14/2019
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 01/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1