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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR MINI TREK CORONARY DILATATION CATHETER Back to Search Results
Model Number 1012270-30
Device Problems Inflation Problem (1310); Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)
Patient Problems Angina (1710); Non specific EKG/ECG Changes (1817)
Event Date 11/02/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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. It was reported that the balloon was not soaked prior to use. It should be noted that the coronary dilatation catheters (cdc), trek rx and mini trek rx, global instructions for use (ifu) preparation for use section states: submerge the balloon in sterile heparinized normal saline during balloon preparation, to activate the coating. In this case, it is unknown if the ifu violation caused or contributed to the reported complaint. The reported patient effect of angina is listed in the coronary dilatation catheters (cdc), trek rx and mini trek rx, global, instructions for use as a known patient effect. The investigation was unable to determine a conclusive cause for the reported leak and inflation issue. However, factors that can contribute to a leak in the system include, but are not limited to, manufacturing, balloon damage during use, inflation technique, interactions with accessory devices, catheter damage, or insufficient preparation prior to use. Subsequently, it is possible that the reported leak contributed to the reported partial inflation of the balloon. The reported additional treatment appears to be related to circumstances of the procedure. A conclusive cause for the reported patient effects of angina and st elevation (ekg/ecg changes) and the relationship to the device, 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 right coronary artery. A 2x30mm mini trek balloon was prepared as usual but not soaked prior to use. The device was advanced to the lesion and when inflated, there was no movement on the manometer but the balloon inflated only a little bit, but was noted as losing pressure. The patient developed chest pain and st-elevation for approximately 5 minutes. The balloon was simply removed and a stent was implanted to successfully treat the chest pain and st elevation. Afterwards when flushing the balloon outside the anatomy, a leakage was noted at the mid shaft. The patient is doing fine. There was no adverse patient sequela and no clinically significant delay. No additional information was provided.
 
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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 Key10870042
MDR Text Key217177440
Report Number2024168-2020-09758
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeSW
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
Report Date 11/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012270-30
Device Catalogue Number1012270-30
Device Lot Number00702G1
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 Received11/02/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/02/2020
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: 11/19/2020 Patient Sequence Number: 1
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