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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 1012455-12
Device Problems Failure to Fold (1255); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/04/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all relevant information.
 
Event Description
It was reported that the procedure was performed to treat a large lesion in the right coronary artery with no tortuosity and no calcification. A 5. 00 x 12 mm nc trek rx balloon dilatation catheter (bdc) was advanced for post dilatation of an unspecified stent. The balloon of the bdc was inflated once to 18 atmospheres. While there was no reported problems with deflation, the balloon of the bdc failed to rewrap properly and met resistance with the 6f non-abbott guide catheter on removal. The balloon was inflated and deflated again; however, continued to not rewrap properly. The bdc was ultimately removed as a single unit with the guide catheter to complete the procedure. 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 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 Key8282988
MDR Text Key134337744
Report Number2024168-2019-00605
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110134
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 02/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/29/2020
Device Catalogue Number1012455-12
Device Lot Number70324G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/11/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/14/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2017
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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