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U.S. Department of Health and Human Services

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

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AV-TEMECULA-CT TREK CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1012272-12
Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/14/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device was received. Investigation is not yet complete. A follow up report will be submitted with all relevant information.
 
Event Description
It was reported that the procedure was to treat the left anterior descending artery for fractional flow reserve using a trapping technique. During pullback of the 2. 5 x 12 mm trek rx balloon catheter after use, resistance was felt inside the guiding catheter and the balloon was observed to have separated and was located inside the guiding catheter. The balloon segment was removed without issue with the guiding catheter leaving nothing in the patient. There was no resistance during removal of the protective sheath or issues noted during preparation of the balloon. No adverse patient effects or clinically significant delay in the procedure were reported. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: visual and dimensional were performed on the returned device. The reported kink was confirmed; however the reported difficulty to remove could not be replicated in a testing environment due to the condition of the returned device. The balloon was not separated; however, the proximal shaft was separated. There was no report of any damage during preparation or prior to use or, which suggests that a product quality issue did not contribute to the reported complaint. In this case, it is possible that the device became kinked during advancement or retraction such that it contributed to the reported resistance and further manipulation likely caused the shaft to separate. 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 identified no other incidents from this lot. The investigation determined the reported complaints appear 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 NameTREK 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 Key6216611
MDR Text Key63838441
Report Number2024168-2016-09418
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103110
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 01/17/2017
1 Device was Involved in the Event
0 Patients were 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 Date06/30/2019
Device Catalogue Number1012272-12
Device Lot Number60711G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer12/22/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/13/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2016
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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