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

Catalog Number	A35HPV12080080
Medical Device Problem Codes	Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Embolism (1829); Device Embedded In Tissue or Plaque (3165)
Date of Event	01/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician attempted to use a fortrex balloon with a non-medtronic 7f x 7cm (boston) and a 0.035 guidewire (boston) to treat a moderately calcified fibrous lesion with 80% stenosis during avf angioplasty accessed through the proximal left cephalic arch with in-stent stenosis.Lesion length and artery diameter were respectively 40mm and 12mm.The device was inspected prior to use and was reported to be in normal and acceptable condition.The device was prepped as per the ifu with no issues identified.An inflation device was used (bard presto).No resistance was experienced during the advancement with the device and it did pass through a previously deployed stent.A circumferential burst was reported during device inflation at 10 atm.Many attempts were made via 2 access points to retrieve the balloon material but they were not successful (dialysis access graft thrombosis and occlusion occurred, rendering the access not usable).The burst of the balloon and subsequent embolization of the left-over balloon material has left the patient¿s dialysis access graft occluded.No excessive force was used.Fragments remains in patient.No attempt to snare the fragment was made because the fistula had thrombosed due to the occlusive nature of the balloon fragment.Further treatment for the patient is pending.The thrombosed fistula will require a surgical excision of the fragment with possible declot at a later date.The patient is reported to be stable currently.
Additional Manufacturer Narrative
Additional information: the fragment was removed from the patient 7 days post initial procedure.The physician was able to declot the fistula after surgical removal of the obstruction device evaluation: the fortrex 0.035in otw pta balloon catheter was received for evaluation within a tyvek pouch that contained two separate plastic pouches.In the nested series sealed biohazard pouches was a zippered closure plastic pouch that contained the balloon catheter and 7fr introducer sheath.A nested series of zippered closure plastic pouches contained a specimen jar that contained the distal segment of the fortrex balloon catheter.No cine images from the procedure were received for evaluation.All components of the fortrex balloon catheter were accounted for.The proximal segment of the balloon catheter included the y-manifold, the catheter, proximal balloon bond, inner guidewire lumen, and both radiopaque marker bands.The balloon chamber material separation face is a radial/circumferential tear.The inner guidewire lumen exhibits tensile stretching and necking down.The damage is consistent with the balloon chamber material bunching up at the mouth of the support catheter during the withdrawal.The distal segment of the balloon catheter included the distal segment of balloon chamber material, and the inner guidewire distal tip.The balloon chamber material was bunched up over the distal tip.The balloon chamber material exhibited both radial and longitudinal tearing.If information is provided in the future, a supplemental report will be issued.

• Brand Name: FORTREX 0.035 OTW PTA BALLOON CATHETER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): MEDTRONIC COVIDIEN; 4600 nathan lane; plymouth MN 55442
• MDR Report Key: 8273558
• Report Number: 2024500-2019-00001
• Device Sequence Number: 16664356
• Product Code: LIT
• UDI-Device Identifier: 00763000106430
• UDI-Public: 00763000106430
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K142654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/25/2021
• Device Catalogue Number: A35HPV12080080
• Device Lot Number: A744182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Initial Date Received by Manufacturer: 01/04/2019
• Supplement Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 01/24/2019
• Supplement Report FDA Received Date: 02/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR