MAUDE Adverse Event Report: COVIDIEN FORTREX 0.035 OTW PTA BALLOON CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess performance of the evercross pta balloon catheter.Survey results received for an interventional cardiologist practicing in spain who within the last 12 months used an evercross pta balloon catheter for dilatation of stenoses in the iliac arteries (26 procedures), femoral arteries (32 procedures), ilio-femoral arteries (16 procedures), popliteal arteries (22 procedures), infra-popliteal arteries (19 procedures), and renal arteries (29 procedures).The evercross pta balloon catheter was also used for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae (6 procedures) and for stent post dilatation in the peripheral vasculature (6 procedures).This interventional cardiologist also used a fortrex pta balloon catheter for dilatation of stenoses in the iliac arteries (23 procedures), femoral arteries (41 procedures), ilio-femoral arteries (19 procedures), popliteal arteries (18 procedures), infra-popliteal arteries (12 procedures), and renal arteries (33 procedures).The evercross pta balloon catheter was also used for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae (9 procedures) and for stent post dilatation in the peripheral vasculature (61 procedures).Related to the evercross pta balloon catheter, two aneurysm events are reported during use for dilatation of stenoses in the femoral arteries and popliteal arteries.Three fever events are reported during use for dilatation of stenoses in the iliac arteries.One venous thromboembolism event is also reported.The aneurysm events are reported to be very concerning.The fever events and venous thromboembolism event are reported to be not at all concerning.One aneurysm event (during percutaneous treatment) is reported to be device related.One fever event is reported to be device related and attributed to local effects.The venous thromboembolism is also reported to be device related and anticoagulant treatment is mentioned.Related to the fortrex pta balloon catheter, one artery perforation or rupture event is reported to have occurred during treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.Two hematoma events are reported during dilatation of stenoses in the iliac arteries and popliteal arteries; and also, during stent post dilatation in the peripheral vasculature.Three haemorrhage events are reported during dilatation of stenoses in the femoral arteries, during treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae, and during stent post dilatation in the peripheral vasculature.The artery perforation or rupture event is reported to be very concerning but not related to the device.The hematoma events were reported to be not at all concerning but one is reported as being related to the device itself and was given local treatment.The haemorrhage events are reported to be somewhat concerning and one is reported to have been related to the device itself and local pressure treatment was applied.

• Brand Name: FORTREX 0.035 OTW PTA BALLOON CATHETER
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9009750
• MDR Text Key: 162336952
• Report Number: 2183870-2019-00444
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K142654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2019
• 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