• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR MINI TREK CORONARY DILATATION CATHETER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ABBOTT VASCULAR MINI TREK CORONARY DILATATION CATHETER Back to Search Results
Model Number 1012270-15
Device Problems Difficult to Remove (1528); Material Rupture (1546); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/01/2022
Event Type  malfunction  
Event Description
It was reported that the procedure was to treat a lesion located in the obtuse marginal that was moderately tortuous and 90% stenosed. The mini trek balloon ruptured during the first inflation at 6 atmospheres. There was resistance met with the lesion during advancement and removal. Another same-sized trek rx was used to continue the procedure. There was no reported adverse patient effect and no clinically significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
The device was not returned for evaluation. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot. The investigation determined the reported complaints appear to be related to operational context. There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMINI TREK CORONARY DILATATION CATHETER
Type of DeviceCORONARY DILATATION CATHETER
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR COSTA RICA, REG # 3009564766
52 calle 3 b31 coyol free zone
el coyol alajuela
CS
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key14802809
MDR Text Key295798378
Report Number2024168-2022-06812
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648138157
UDI-Public08717648138157
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K103110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial
Report Date 06/24/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012270-15
Device Catalogue Number1012270-15
Device Lot Number10914G2
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/14/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-