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

Model Number	A35HPV12040080
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Occlusion (1984); Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)
Date of Event	08/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was attempting to treat a 40mm calcified lesion located in the left proximal common iliac artery with a fortrex pta balloon catheter.A 7f non-medtronic sheath and a 0.35 guidewire were used for the procedure.The lesion exhibited a severe degree of tortuosity and a severe degree of calcification with an unknown % lesion stenosis.The diameter of the artery is 12mm.Embolic protection was not used.The balloon was inflated using an inflation device using 50/50 fluid.The device was prepped per the ifu with no issues identified.The device passed through a previously deployed stent but no resistance was encountered when advancing the catheter and excessive force was not used.It was reported the balloon catheter detached/cracked/fractured and the balloon stripped off during removal from a patient.The break/fracture occurred at the balloon catheter and the detached portion of the device remained in the patient.The physician used bronchoscopy forceps during the procedure to remove what he believed to be all the remnants left in the body.Several hours post procedure, an ultrasound determined a flow defect.The patient experienced vessel occlusion due to the device component which remained in the left proximal common iliac artery.The patient was brought back to the operating theatre to stent the flow defect which was believed to be a remnant of the balloon.The physician stated that the products performed as expected and that the event was due to the anatomical difficulties of the case.

• 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: 6867135
• Report Number: 2183870-2017-00398
• Device Sequence Number: 108018
• Product Code: LIT
• UDI-Device Identifier: 00821684057872
• UDI-Public: 00821684057872
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 08/16/2017

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: 03/25/2019
• Device Model Number: A35HPV12040080
• Device Catalogue Number: A35HPV12040080
• Device Lot Number: A249837
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2017
• Initial Report FDA Received Date: 09/14/2017
• 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: 83 YR