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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
Model Number 1012453-15
Device Problems Deflation Problem (1149); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/04/2021
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 to treat a 90% stenosed, heavily calcified and moderately tortuous vessel in the left anterior descending (lad) artery. The 4. 0x15mm nc trek balloon dilatation catheter (bdc) was soaked prior to use but was not prepped (air aspiration) outside the anatomy. It reached the target lesion and was inflated 2-3 times with a pressure of 12 atmospheres (atms) each time with a contrast mix of 100%. Negative pressure was held for 2 or 3 seconds upon deflation and the balloon could only be partially deflated. The physician decided to remove everything as a single unit. Another non-abbott balloon was used to complete the procedure. There was no adverse patient effect and there was no significant delay in the procedure. 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 Key12700978
MDR Text Key278803975
Report Number2024168-2021-09623
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeHK
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 10/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012453-15
Device Catalogue Number1012453-15
Device Lot Number10409G1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/09/2021
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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