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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 1012447-12
Device Problem Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/20/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information. The device was not returned for evaluation. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue. The investigation determined the reported difficulty appears to be related to circumstances of the procedure. There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
 
Event Description
It was reported that the procedure was to treat a 90% stenosed, moderately tortuous, and moderately calcified lesion in the mid left anterior descending artery. A 2. 5x12mm nc trek balloon dilatation catheter was used for pre-dilatation; however, the balloon ruptured during the first inflation at 8 atmospheres. No further pre-dilatation was performed and the procedure was successfully completed with the deployment of a non-abbott stent. There was no clinically significant delay in the procedure and no adverse patient effects. 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 Key6216644
MDR Text Key63842682
Report Number2024168-2016-09424
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeJA
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
Report Date 12/30/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2017
Device Catalogue Number1012447-12
Device Lot Number41001G1
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 Received12/22/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2014
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: 12/30/2016 Patient Sequence Number: 1
Treatment
GUIDE WIRE: SIONGUIDE CATHETER: HYPERION
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