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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 1012274-20
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 10/07/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).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 left anterior descending artery.Pre-dilatation was performed with a 3.0x20 trek balloon dilatation catheter.Three inflations were performed at 16 atmospheres (atm), 18 atm and 22atm.At the third inflation at 22atm, the balloon burst, got caught within a vessel and part of the balloon remained in the anatomy.A micro catheter, second unspecified wire were placed and an unknown drug-eluting stent was used to embed the separated balloon portion to the vessel wall.The account noted that there was a clinically significant delay which caused an occlusion due to the trek balloon.The occlusion was treated with three other balloons and drug-eluting stents to successfully complete the procedure successfully.There was no patient sequela.No additional information was provided.
 
Manufacturer Narrative
Device code 2017 - excessive force.Visual and sem inspections/analysis were performed on the returned device.The reported balloon rupture and separations were confirmed.The reported entrapment of device could not be replicated in a testing environment as it was based on operational circumstances.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/complaints from this lot.It was reported that the balloon was inflated three times at 16 atmospheres (atm), 18 atm and 22atm.At the third inflation at 22atm, the balloon ruptured.It should be noted that the coronary dilatation catheters (cdc), trek rx global, instruction for use states: balloon pressure should not exceed the rated burst pressure (rbp).The investigation determined the reported balloon rupture appears to be related to user error; however, the reported entrapment of device and balloon separation appear to be related to operational context.A conclusive cause for the reported patient effects of device embedded and occlusion and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
 
Event Description
It was reported that the procedure was to treat a left anterior descending artery.Pre-dilatation was performed with a 3.0x20 trek balloon dilatation catheter.Three inflations were performed at 16 atmospheres (atm), 18 atm and 22atm.At the third inflation at 22atm, the balloon burst, got caught within a vessel and part of the balloon remained in the anatomy.A micro catheter, second unspecified wire were placed and an unknown drug-eluting stent was used to embed the separated balloon portion to the vessel wall.The account noted that there was a clinically significant delay which caused an occlusion due to the trek balloon.The occlusion was treated with three other balloons and drug-eluting stents to successfully complete the procedure successfully.There was no patient sequela.No additional information was provided.Correction to b5: it required multiple attempts and some force to remove the device.
 
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Brand Name
TREK RX CORONARY DILATATION CATHETER
Type of Device
CORONARY DILATATION CATHETER
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
MDR Report Key9261144
MDR Text Key164668491
Report Number2024168-2019-13082
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648138447
UDI-Public08717648138447
Combination Product (y/n)N
PMA/PMN Number
K103110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2022
Device Model Number1012274-20
Device Catalogue Number1012274-20
Device Lot Number90325G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/07/2019
Date Manufacturer Received02/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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