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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT NC TREK CORONARY DILATATION CATHETER

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AV-TEMECULA-CT NC TREK CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1012448-15
Device Problems Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Component Missing (2306)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/29/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Date of event - estimated. (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 during an intervention, when the nc trek balloon dilatation catheter entered into the patient, the physician recognized that there was no balloon crimped on the hypotube. The device was removed and another balloon catheter was used to finish the procedure. It did not fall off, nor was lost in the patient, or in the sheath, it was simply missing completely. The physician did not inspect the device thoroughly before use, so he realized it when the device was already in the patient. There was no reported adverse patient effect or a clinically 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)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
EL COYOL, COSTA RICA REG# 3009031392
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer Contact
connie speck
abbott vascular
26531 ynez road
temecula, CA 92591-4628
9519143996
MDR Report Key8360578
MDR Text Key136853849
Report Number2024168-2019-01332
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K110134
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 06/14/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2019
Device Catalogue Number1012448-15
Device Lot Number60202G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/28/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/04/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-2037-2039-2017

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