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U.S. Department of Health and Human Services

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

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COVIDIEN FORTREX 0.035 OTW PTA BALLOON CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number A35HPV12040080
Device Problem Detachment of Device or Device Component (2907)
Patient Problems Occlusion (1984); Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)
Event Date 08/16/2017
Event Type  Injury  
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 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.
 
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Brand NameFORTREX 0.035 OTW PTA BALLOON CATHETER
Type of DeviceCATHETER, 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 Key6867135
MDR Text Key86254072
Report Number2183870-2017-00398
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142654
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Remedial Action Notification
Type of Report Initial
Report Date 08/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/25/2019
Device Model NumberA35HPV12040080
Device Catalogue NumberA35HPV12040080
Device Lot NumberA249837
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/16/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/25/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/14/2017 Patient Sequence Number: 1
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