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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 1012275-12
Device Problems Entrapment of Device (1212); Material Rupture (1546); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Occlusion (1984)
Event Date 11/18/2019
Event Type  Injury  
Manufacturer Narrative
Exemption number (b)(4). The customer reported the device is not returning. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was performed to treat a heavily calcified circumflex lesion. A 3. 25x12mm rx trek balloon ruptured at 18 atmospheres on the second inflation. The balloon dilatation catheter (bdc) met resistance with the anatomy during retrieval and the balloon separated in the anatomy. An attempt was made to retrieve the separated balloon using an unspecified guide liner but was unsuccessful and the balloon was left in the vessel. Although the vessel was totally occluded, treatment was not done as the vessel had collaterals to the area from other vessels. Once the rx trek became stuck in the vessel, it contributed to the balance middleweight (bmw) universal ii guidewire and a non-abbott guidewire to lose distal access. The guide wire was replaced with a wiggle wire guidewire. Per the account, there was no issue with the bmw. There was no adverse patient sequela reported. 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 Key9432803
MDR Text Key169849592
Report Number2024168-2019-14250
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648138492
UDI-Public08717648138492
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103110
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
Report Date 07/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2022
Device Model Number1012275-12
Device Catalogue Number1012275-12
Device Lot Number90207G1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/07/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/06/2019 Patient Sequence Number: 1
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