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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR TREK RX CORONARY DILATATION CATHETER Back to Search Results
Model Number 1012276-15
Device Problem Deflation Problem (1149)
Patient Problem Intimal Dissection (1333)
Event Date 05/21/2020
Event Type  Injury  
Manufacturer Narrative
The device was not returned for analysis. 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 incidents from this lot. The reported patient effect of dissection is listed in the trek rx and mini trek rx coronary dilatation catheter instructions for use as a known patient effect of coronary procedures. As the device was not returned for analysis, the investigation determined a conclusive cause for the reported deflation problem cannot be determined. The reported difficulties possibly contributed to the reported patient effects; however a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
It was reported that the procedure was performed to treat a mildly calcified, non-tortuous right coronary artery. The 3. 50x15mm rx trek balloon was pressurized three times to 16atm, then the balloon failed to deflate. After several attempts were made to deflate the balloon and pulling negative for more than 2 minutes, the balloon was retrieved inflated causing a small dissection. The dissection was treated with an unspecified stent and balloon. There was no adverse patient sequela reported. No additional information was provided.
 
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Brand NameTREK RX
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 Key10148847
MDR Text Key195087248
Report Number2024168-2020-04972
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCI
PMA/PMN Number
K103110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 06/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012276-15
Device Catalogue Number1012276-15
Device Lot Number91206G1
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 Received05/22/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/06/2019
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: 06/12/2020 Patient Sequence Number: 1
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