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

Catalog Number A35HPV12080080

Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)

Patient Problems Embolism (1829); Device Embedded In Tissue or Plaque (3165)

Event Date 12/21/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician attempted to use a fortrex balloon with a non-medtronic 7fr x 7cm sheath (boston) and a 0.035 wire (terumo glidewire) to treat a slightly calcified fibrous lesion, slightly tortuous, with 80% stenosis during avf angioplasty in the proximal upper left cephalic vein.Lesion length and artery diameter were respectively 40mm and 12 mm.The device was prepped as per the ifu and no issues were noted.An inflation device (bard presto) was used.A circumferential balloon burst was reported during inflation of the device at 10 atm.Difficulty was encountered when attempting to retrieve the device from the patient and this resulted in shaft detachment.The fragment migrated to the upper arm basilica vein.The physician placed a non-medtronic (bard 12x60 covera) self-expanding covered stent in the arm of the balloon embolization, entrapping the balloon distal tip and the shaft.No snare was attempted due to the size and configuration of fragment and risk of further embolization centrally.The patient's fistula is working well.

Manufacturer Narrative

Device evaluation: the fortrex 0.035in otw pta balloon catheter was received for evaluation within a sealed tyvek pouch, within a nested series of sealed plastic biohazard pouches, and loosely coiled within a zippered closure pouch.No ancillary devices or cine images from the procedure were received for evaluation.The fortrex balloon catheter was visually and tactile inspected.No abnormalities were noted in the catheter between the y-manifold and the proximal balloon bond.Approximately 55mm of the 80mm length balloon chamber were received.The balloon chamber material exhibited radial and longitudinal tearing.The inner guidewire lumen was examined: the proximal radiopaque marker band was present, and the remaining inner guidewire lumen exhibits tensile stretching.Not all components of the fortrex balloon catheter were returned.Approximately 2.5mm of balloon chamber length material were not received.The distal radiopaque marker band and the catheter¿s distal tip were not returned.If information is provided in the future, a supplemental report will be issued.

• 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: 8273905
• MDR Text Key: 134012494
• Report Number: 2183870-2019-00029
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00763000106430
• UDI-Public: 00763000106430
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2021
• Device Catalogue Number: A35HPV12080080
• Device Lot Number: A744172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR