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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
Catalog Number 1012270-12
Device Problems Inflation Problem (1310); Material Split, Cut or Torn (4008)
Patient Problems Air Embolism (1697); Angina (1710); Non specific EKG/ECG Changes (1817)
Event Date 02/25/2021
Event Type  Injury  
Manufacturer Narrative
The date of event will be estimated as (b)(6) 2021.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 performed to treat an unspecified lesion.The trek balloon dilatation catheter (size not specified) had a hole in the shaft.The hole in the shaft caused air to enter the patient.Treatment, if any, was not reported.There was no adverse patient sequela reported.No additional information was provided.
 
Event Description
It was reported that the procedure was performed to treat an unspecified lesion.The trek balloon dilatation catheter (size not specified) had a hole in the shaft.The hole in the shaft caused air to enter the patient.Treatment, if any, was not reported.There was no adverse patient sequela reported.Subsequent to the initially filed report, the following information was received: it was reported that the procedure was performed to treat a moderate to heavily calcified and non-tortuous right coronary artery (rca).The 2.0x12mm mini trek balloon failed to inflate.The device was removed and inspected.A hole was found in the shaft.The hole in the shaft caused air to enter the patient.The air caused no reflow in the posterior lateral branch of the rca due to air embolism as well as elevated st and mild chest pain.The patient was treated with additional ballooning.A new trek balloon was used to successfully complete the procedure.There was no adverse patient sequela reported.No additional information was provided.
 
Manufacturer Narrative
Visual and functional inspections were performed on the returned device.The reported tear and inflation issue were confirmed.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 of the reported lot did not indicate a lot specific quality issue.The reported patient effects of air embolism and angina are listed in the coronary dilatation catheters (cdc), trek rx and mini trek rx, global, instructions for use as known patient effects.The investigation determined the reported tear, inflation issue and additional treatment appear to be related to operational context.A conclusive cause for the reported patient effects of air embolism, 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.B3: date of event changed from (b)(6) 2021 to (b)(6) 2021.
 
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Brand Name
MINI TREK CORONARY DILATATION CATHETER
Type of Device
CORONARY DILATATION CATHETER
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
MDR Report Key11509500
MDR Text Key240596330
Report Number2024168-2021-02122
Device Sequence Number1
Product Code LOX
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,health
Type of Report Initial,Followup
Report Date 05/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2022
Device Catalogue Number1012270-12
Device Lot Number90925G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/26/2021
Date Manufacturer Received05/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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