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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR NC TREK CORONARY DILATATION CATHETER Back to Search Results
Catalog Number UNK NC TREK
Device Problem Material Separation (1562)
Patient Problem Insufficient Information (4580)
Event Date 06/01/2021
Event Type  Injury  
Manufacturer Narrative
Date of event: estimated date. The udi number is not known as the part and lot number were not provided. The device was not returned for evaluation. A review of the lot history record and complaint history of the reported device 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 separation; however, the reported additional treatment and removal of foreign body appear to be related to circumstances of the procedure. 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 during use of the 2. 50x20 mm nc trek balloon dilatation catheter (unknown if rapid exchange (rx) or over the wire (otw)), the front part of the catheter (approximately 20 cm) was torn off. The torn portion was retrieved via snare. No additional information was provided.
 
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Brand NameNC 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 Key12124804
MDR Text Key260210852
Report Number2024168-2021-05739
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K103153
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 07/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2021
Is this an Adverse Event Report? Yes
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 Received06/15/2021
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

Patient Treatment Data
Date Received: 07/06/2021 Patient Sequence Number: 1
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