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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 1012451-15
Device Problem Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/30/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The customer reported the device was discarded. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat a lesion in the mildly tortuous, heavily calcified, 90% stenosed proximal left anterior descending (lad) coronary artery. A 3. 50 x15 mm nc trek rx balloon dilatation catheter (bdc) was selected for the procedure. The bdc was advanced with no resistance to the lesion. Upon the first inflation of the balloon to 12 atmospheres, the balloon ruptured. The bdc was replaced with a 3. 50 x 15 mm non-abbott bdc and the procedure was successfully completed with the implant of an unspecified stent. There was no reported clinically significant delay in the procedure. There was no reported adverse patient sequela. No additional information was provided.
 
Manufacturer Narrative
(b)(4). The device was not returned for evaluation. However, there was no leak noted during preparation prior to use, which suggests a product quality issue did not contribute to the reported difficulties. In this case it is likely that the balloon interacted with the mildly tortuous, heavily calcified and 90% stenosed lesion such that the balloon became damaged and subsequently ruptured during inflation. 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.
 
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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)
ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168
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 Key6191959
MDR Text Key62969580
Report Number2024168-2016-09082
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,distri
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 01/09/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/20/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2018
Device Catalogue Number1012451-15
Device Lot Number5101661
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 Received12/21/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2015
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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