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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); Material Rupture (1546); Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/25/2020
Event Type  malfunction  
Manufacturer Narrative
The device was returned for analysis. The reported inflation problem was able to be confirmed. Additionally returned goods analysis identified there was fluid was leaking from the tip at 16 atmospheres. There was a pinhole in the proximal taper of the balloon and a tear noted in the inner member. 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. As there was no report of a leak during preparation for use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the guide wire and/or other devices resulted in the noted inner member tear, the noted scratched proximal balloon marker and the noted balloon material pinhole; thus resulting in the reported inflation problem/noted leaks (pinhole, tip). The noted multiple bends on the hypotube likely occurred due to handling or during packing for return analysis. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
It was reported that a 2. 0x30mm mini trek rx balloon dilatation catheter failed to inflate. The procedure was successfully completed with an unspecified balloon catheter. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided. Returned goods analysis identified there was fluid was leaking from the tip at 16 atmospheres. There was a pinhole in the proximal taper of the balloon and a tear noted in the inner member.
 
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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 Key10708737
MDR Text Key212287519
Report Number2024168-2020-08761
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCA
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 10/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2021
Device Model Number1012270-30
Device Catalogue Number1012270-30
Device Lot Number81212G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/23/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/12/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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