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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

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ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER Back to Search Results
Model Number 1012278-30
Device Problems Deflation Problem (1149); Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/10/2020
Event Type  malfunction  
Manufacturer Narrative
The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat a lesion in the pulmonary artery. After the 4. 00x30 mm trek balloon dilatation catheter (bdc) was used for dilation about 10 times to 6-8 atmospheres, the balloon failed to deflate. Negative pressure was held for 5-6 seconds. The bdc was removed together with the 6fr introducer as the balloon remained inflated at 50%. Reportedly, the device was not prepped (air aspiration) prior to use. The patient had another puncture to place another introducer and to complete the procedure. No additional information was provided.
 
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Brand NameTREK 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 Key9958999
MDR Text Key187702386
Report Number2024168-2020-03648
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648138744
UDI-Public08717648138744
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K103110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2022
Device Model Number1012278-30
Device Catalogue Number1012278-30
Device Lot Number91008G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/19/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/08/2019
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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