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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR UNKNOWN TREK DILATATION CATHETER

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ABBOTT VASCULAR UNKNOWN TREK DILATATION CATHETER Back to Search Results
Catalog Number UNK NC TREK
Device Problem Deflation Problem (1149)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/05/2020
Event Type  malfunction  
Manufacturer Narrative
Estimated date of event. The device was not returned for evaluation. A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot numbers were not provided. The investigation was unable to determine a conclusive cause for the reported deflation issue since the device was not returned for analysis and limited information was provided. There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
 
Event Description
It was reported that an unk nc trek balloon would not deflate entirely within the stent. There were no reported adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
 
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Brand NameUNKNOWN TREK
Type of DeviceDILATATION 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 Key10083462
MDR Text Key193359133
Report Number2024168-2020-04473
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K103110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 05/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK NC TREK
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 Received05/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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