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

Catalog Number	A35HPV07040135
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Cine evaluation: the customer provided a cine of the vessel undergoing treatment.The cine was able to show the distal end of the introducer sheath and an implanted stent within the vessel.Stenosis was noted at the medial location of the deployed stent.It could not be determined if the severity of the observed stenosis restricted/interfered the ability of the fortex to track through the stent.Product analysis: the fortrex was returned for evaluation.The fortrex was removed from the pouch and inspected.It was discovered dried blood was inside the balloon segment of the catheter.No damages were observed to the fortrex.A 0.035" gw was attempted to be loaded through the catheter; however, resistance was encountered likely due to an obstruction related to biologics entering the gw lumen.An inflation device filled with water was connected to the balloon port of the manifold.As pressure was applied, a spray of fluid was observed coming from a hole to the balloon.The hole was located approximately 2.5cm from the distal tip.The leak was coming from a pinhole on the balloon.The area of the leak was inspected and could observe bubbles at the area of the pin hole where the leak was identified.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician intended to use a fortrex hp pta balloon with a 6fr sheath and 0.014 x 300 cm nitrex wire during treatment of a 30mm plaque lesion in the patient¿s mid and proximal right common iliac artery of diameter 7-8mm.Slight calcification and tortuosity are reported.Lesion exhibited 60% stenosis.A steep aortic bifurcation is also reported.Protégé gps was deployed without issue prior to use of the fortrex.Ifu was followed.Resistance was encountered during advancement of the fortrex.The device was passed through a previously deployed stent.Device prepped without issue.Negative prep was not performed.No leaks were noted from balloon/ports during prep.The physician attempted to advance the fortrex balloon catheter through the existing sheath in attempt to cross the lesion for treatment, resistance was felt as the balloon would not cross the lesion resulting in the sheath backing up out of its original desired position therefore could not provide support for balloon cross.The 014 wire was exchanged for a 035 non-medtronic wire through pta.Multiple attempts to access contralateral side then successful.The sheath was successfully advanced over aorta, pta advance d in stent, attempted inflation unsuccessfully.A non-medtronic inflation device with (ultravist/hepsal 60/40) inflation fluid was used for balloon inflation.Balloon inflation difficulties were noted at a pressure of 6atm.The fortrex would not hold pressure.The fortrex was then removed intact without difficulty.Nanocross 6x60 used without difficulties to complete the procedure.The nanocross was inflated to 14atm for 90sec then increased to 18atm for 90 more secs.No patient injury reported.

• Brand Name: FORTREX 0.035 OTW PTA BALLOON CATHETER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 9231498
• Report Number: 2183870-2019-00517
• Device Sequence Number: 13998485
• Product Code: LIT
• UDI-Device Identifier: 00763000106119
• UDI-Public: 00763000106119
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 10/24/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/05/2022
• Device Catalogue Number: A35HPV07040135
• Device Lot Number: A826555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 10/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 84