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

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

Patient Problem Restenosis (4576)

Event Date 07/13/2021

Event Type  Injury  

Manufacturer Narrative

Title: sharp needle recanalization technique for peripheral hemodialysis arteriovenous fistula occlusion author: seung yeon noh, dong erk goo, yong jae kim journal: cardiovascular and interventional radiology.Year: 2021 vol/issue: 44 ref: 10.1007/s00270-021-02809-1.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted detailing a study to determine the efficacy of a percutaneous sharp needle recanalization technique for the treatment of peripheral hemodialysis arteriovenous fistula (avf) occlusion.13 patients, 14 procedures with non-thrombotic avf occlusion wherein guidewire passage through the occluded segment had failed were included in the study.Medtronic¿s fortrex balloon was identified as one of the balloon catheters used during procedures.Once the presence of occlusion was confirmed by fistulography, which was compared with the previous fistulograms, pta was attempted by antegrade or retrograde approaches using a 5-french angiographic catheter and 0.035-inch hydrophilic guidewires.If the conventional approach failed, a new vascular introducer sheath was inserted from the opposite side of the occluded segment, that is, the antegrade or retrograde direction opposite to that of the initially inserted vascular sheath; both proximal and distal approaches were therefore available.In some cases, when the occluded segment was located in the proximal upper arm or axillary area, new vascular access via the ipsilateral internal jugular vein was created.Fistulograms were performed simultaneously from both sides to determine the exact length and anatomic information of the occluded segment.Under ultrasound or fluoroscopic guidance, sharp needle recanalization was performed using a 21-gauge non-medtronic needle.In cases where a retrograde approach was used, the bulging distal segment was easily punctured.Ultrasound could be easily performed when the lesion was located in the forearm or distal upper arm, or when the distance from the secondary puncture site to the lesion was short with a straight course.A non-medtronic needle was used with direct visualization of the needle tip in such cases.When the lesion was in the axillary area or when the distance between the sheath and the lesion was long with a tortuous course, non-medtronic needle was used under fluoroscopic guidance.After successfully passing the guidewire through the occluded segment, angioplasty was performed using a balloon catheter appropriate to the size of the adjacent vessel.After treating the simultaneous stenotic lesion if present, a final fistulogram was performed to confirm the patency of the previously occluded segment and the central venous system, and there was no additional contrast leakage from the recanalized tract.Technical success was achieved in 12 (85.7%) out of 14 procedures.The procedure failed in two patients due to the poor angle of approach in the axillary area and diffuse severe stenosis in the draining cephalic vein.In eight procedures, sharp needle recanalization was performed under ultrasound guidance, while the other six procedures were performed under fluoroscopic guidance.Non-medtronic needles were used in five and nine procedures, respectively.The mean length of occlusion was 2.7 cm (range 1.8¿4.2 cm).There was one case of mild complication, that is, mild contrast extravasation, which was treated by stent deployment.Hematoma at the direct puncture site with minor contrast extravasation occurred in one patient, which was treated using a self-expandable non-medtronic metal stent.In two patients, a non-medtronic stent was deployed because of severe elastic recoil after balloon angioplasty.During the follow-up period, further pta using pl ain balloons and surgery were performed for restenosis in nine and four patients, respectively.The post-intervention primary patency rates at 6 months, 1 year, and 2 years were 81.8%, 36.4%, and 18.2%, respectively.

• Brand Name: FORTREX 0.035 OTW PTA BALLOON CATHETER
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• 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 ; EI ; 091708734
• MDR Report Key: 13236613
• MDR Text Key: 289002709
• Report Number: 2183870-2022-00021
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K142654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female