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

Model Number 12TLW404F

Device Problems Difficult to Insert (1316); Material Separation (1562); Component Missing (2306); Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 04/22/2019

Event Type  malfunction  

Manufacturer Narrative

Our product evaluation laboratory received one model 12tlw404f catheter.As received, the catheter body appeared to have been stretched and was broken at approximately 9.5cm distal from the 10cm marking.The distal tip was missing.The balloon latex, with both balloon windings and bushings, was detached from the proximal bushing bond and were also missing.A device history record review was completed and documented that the device met all specifications upon distribution.The customer report of "balloon came off of the tip" was confirmed on evaluation.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.Udi # (b)(4).

Event Description

It was reported that during use in a fistula de-clot procedure, the balloon on the tip of the fogarty catheter came off.A full angiogram was performed and could not locate the balloon.A second catheter was then used, but the clinician had difficulty inserting it over the guidewire.Therefore, a third catheter was used and worked successfully.The patient was released the same day and in good health.Patient demographics were requested and not provided.

Manufacturer Narrative

Corrected data: f10, h6.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: 8634399
• MDR Text Key: 146375866
• Report Number: 2015691-2019-01828
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/03/2019

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: 01/22/2021
• Device Model Number: 12TLW404F
• Device Catalogue Number: 12TLW404F
• Device Lot Number: 61525316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Initial Date Manufacturer Received: 05/03/2019
• Initial Date FDA Received: 05/22/2019
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1