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

Model Number 120804F

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/17/2020

Event Type  malfunction  

Manufacturer Narrative

One 120804f catheter was returned for examination.The reported event of "balloon burst" was not confirmed.However, the balloon and windings were detached from the catheter and the balloon and windings were not returned.No visible damage was observed from catheter body.A review of the manufacturing records indicated that the product met specifications upon release.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this 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 arterial 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 the balloon burst and they could not get the wire out.As to date the customer has not responded to attempts made for additional information.Patient demographics were unable to be obtained.

Manufacturer Narrative

Additional details were provided by the hospital that the balloon burst inside the patient¿s lower leg, the wire and balloon tip were not able to be retrieved.However, per the radiologist after reviewing an x-ray, no foreign body was found inside the patient leg.There was no further details provided about the event.

• Brand Name: FOGARTY ARTERIAL EMBOLECTOMY CATHETER
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco PR
• MDR Report Key: 11248013
• MDR Text Key: 229611658
• Report Number: 2015691-2021-00244
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

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: 10/27/2022
• Device Model Number: 120804F
• Device Catalogue Number: 120804F
• Device Lot Number: 63301452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Initial Date Manufacturer Received: 01/12/2021
• Initial Date FDA Received: 01/28/2021
• Supplement Dates Manufacturer Received: 01/29/2021
• Supplement Dates FDA Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1