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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 1012270-12
Device Problems Deflation Problem (1149); Inflation Problem (1310); Difficult to Remove (1528)
Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)
Event Date 12/30/2021
Event Type  Injury  
Event Description
It was reported that the procedure was to treat a chronic totally occluded lesion in an unspecified artery. The 2. 0x12mm mini trek balloon dilatation catheter (bdc) had resistance during inflation to pre-dilate the lesion and was inflated once up to 6 atmospheres (atms). The physician tried to deflate the bdc many times and during attempted removal the bdc got stuck in the patient. Negative was held for 4 seconds to try to deflate the balloon. The bdc was ultimately removed as a single unit. The patient experienced bradycardia and hypotension and atropine was given. There was no prolonged hospitalization, however, there was a delay in the procedure to treat the patient. No additional information was provided.
 
Manufacturer Narrative
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.
 
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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 Key13315566
MDR Text Key284193815
Report Number2024168-2022-00725
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648138140
UDI-Public08717648138140
Combination Product (y/n)N
Reporter Country CodeSA
PMA/PMN Number
K103110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012270-12
Device Catalogue Number1012270-12
Device Lot Number10513G2
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/13/2021
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: 01/21/2022 Patient Sequence Number: 1
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