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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 A35HPV10080080
Device Problem Material Rupture (1546)
Patient Problem Embolism (1829)
Event Date 11/18/2015
Event Type  Injury  
Manufacturer Narrative

A review of the manufacture records for this device did not reveal any discrepancies relevant to the reported event. (b)(4).

 
Event Description

The balloon was being used inside a vein graft where a stent had been previously placed restenosed. The fortrex 10x80 balloon burst at 15 atms (rbp 16atms) and became entrapped on the stent. The physician was unable to remove the balloon. The physician had to perform a cut down at the site of the 7f sheath in order to remove the balloon from the body. The patient is stable. Evaluation of the returned fortrex balloon confirmed the reported event. The balloon was received exhibiting a radial tear. All components of the device are accounted for.

 
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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 n
plymouth MN 55442
Manufacturer Contact
mary haufek
4600 nathan lane n
plymouth, MN 55442
7633987000
MDR Report Key5291150
MDR Text Key33327546
Report Number2183870-2015-07578
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK142654
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 11/18/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/11/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/22/2018
Device MODEL NumberA35HPV10080080
Device Catalogue NumberA35HPV10080080
Device LOT NumberA177639
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/02/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/18/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/23/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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