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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 A35HPV10080080
Device Problem Burst Container or Vessel (1074)
Patient Problems Hemorrhage/Bleeding (1888); Patient Problem/Medical Problem (2688)
Event Date 08/30/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician attempted to use a fortrex balloon with a non-medtronic 7 fr sheath for the treatment of a non-calcified, fibrous fistulae in the right arm. The lesion presented little tortuosity and 60% stenosis. Artery diameter is 10 cm. The device was prepped as per the ifu with no issues identified. The balloon was not passed through a previously deployed stent. There was no resistance encountered on advancement. A medtronic inflation device was used for balloon inflation. It was reported that a circumferential/radial balloon burst occurred during inflation at 18atm. An incision had to be performed on the fistulae to retrieve the balloon fragments from the vasculature. All balloon fragments were removed from the patient. It is also reported that the patient had hemorrhage/bleeding in the access site.
 
Manufacturer Narrative
Product analysis: the fortrex was returned for evaluation. A 7 f sheath was returned as well. No other ancillary devices were included. The fortrex was loaded inside the introducer. Dried blood was observed throughout the returned devices. A radial balloon burst was identified. The catheter fractured at the distal end between the marker bands into two segments. The approximate length of the proximal segment of the catheter was 78cm. The distal edge of the fracture face of the proximal segment showed ductile fracture (photo 9). The balloon burst was radial and the proximal marker band was identified within the balloon segment. The distal segment of the balloon burst/catheter fracture was inspected. The balloon material was compressed/buckled. After stretching out the balloon material the distal segment of the catheter was identified. The distal segment of the blue catheter was identified. The distal marker band was identified on the catheter. No marker band dislodgment identified. The fractured off distal piece of the balloon showed the balloon material bunched up and the distal portion of the catheter was included. The distal marker band was identified after stretching out the balloon material. The proximal segment of the returned device showed a ductile fracture face consistent was exposed to excessive tensile fo rces. The proximal marker band was identified within the balloon. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Additional information: the balloon burst occurred on the first inflation. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Additional information: no treatment required for access site bleeding/hemorrhage. If information is provided in the future, a supplemental report will be issued.
 
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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 Key8964071
MDR Text Key156571364
Report Number2183870-2019-00428
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
Type of Report Initial,Followup,Followup,Followup
Report Date 11/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberA35HPV10080080
Device Lot NumberA861251
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/15/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/14/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/09/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/05/2019 Patient Sequence Number: 1
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