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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR NC TREK RX & VOYAGER NC CORONARY DILATATION CATHETER Back to Search Results
Model Number 1012455-08
Device Problems Deflation Problem (1149); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/21/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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 a mid-left anterior descending artery that was 85% stenosed. A non-abbott guide wire crossed the lesion. A 5. 0x8mm rx nc trek balloon was used for dilatation (inflated once at 18atms). Negative pressure was pulled for 60-90 seconds but the balloon could not be deflated, and it became stuck with the unspecified 7f guiding catheter. After several attempts to deflate, the balloon only partially deflated and could not be refolded. The entire system was removed as a single unit. Reportedly, the device was not prepped (air aspiration) outside the anatomy prior to use. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
 
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Brand NameNC TREK RX & VOYAGER NC
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 Key10028664
MDR Text Key191841989
Report Number2024168-2020-04131
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648152139
UDI-Public08717648152139
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K103153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012455-08
Device Catalogue Number1012455-08
Device Lot Number00115G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/18/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/03/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/15/2020
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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