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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, TRANSLUMINA

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COVIDIEN FORTREX 0.035 OTW PTA BALLOON CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA Back to Search Results
Model Number A35HPV06100080
Device Problems Inflation Problem (1310); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/01/2021
Event Type  malfunction  
Manufacturer Narrative
Image review: the customer returned one image. The image appears to show inflated balloon in a patient¿s vasculature. The middle of the balloon is not inflated which could indicate a twist in the balloon. However, this is a hypothesis and cannot be positively determined. The 2 balloon marker bands are visible in the image also. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician attempted to use an fortrex hp pta balloon catheter during patient treatment. There was no damage noted to packaging, i. E. Shelf carton, hoop/tray. No issues were noted when removing the device from the hoop/tray. Ifu was followed and the device was prepped without issue. An inflation device was used for balloon inflation. The device did not pass through a previously deployed stent. No resistance was noted during advancement. It is reported balloon inflation difficulties occurred when device was inflated to nominal burst pressure. There was no leak noted in the device. The balloon did not burst. The device was safely removed from the patient. A new fortrex device was used to complete the procedure. No patient injury reported.
 
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Brand NameFORTREX 0.035 OTW PTA BALLOON CATHETER
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
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 
EI  
091708734
MDR Report Key13003890
MDR Text Key285011018
Report Number2183870-2021-00455
Device Sequence Number1
Product Code LIT
UDI-Device Identifier00763000106041
UDI-Public00763000106041
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
K142654
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberA35HPV06100080
Device Catalogue NumberA35HPV06100080
Device Lot NumberB185950
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/09/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/05/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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