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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
Catalog Number A35HPV12080080
Device Problems Material Rupture (1546); Migration (4003)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 12/27/2018
Event Type  Injury  
Event Description
During "fistologram" balloon catheter burst resulting in retained fragments; patient taken "emergency" to operating room for removal of retained fragments via venotomy. This was unsuccessful; patient was admitted to hospital and taken the next day for repeat fistulogram where fragments were noted to be subclavian vein near proximal stent, which were trapped by deploying a stent.
 
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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
MDR Report Key8276855
MDR Text Key134066731
Report Number8276855
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 01/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberA35HPV12080080
Device Lot NumberA744172
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/24/2019
Event Location Hospital
Date Report to Manufacturer01/25/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/25/2019 Patient Sequence Number: 1
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