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U.S. Department of Health and Human Services

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

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AV-TEMECULA-CT TRAVELER RX CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1013069-15
Device Problems Difficult to Remove (1528); Physical Resistance (2578); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/15/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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 identified no other incidents from this lot. The investigation determined the reported difficulties 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. The additional traveler device is being filed under a separate medwatch report. The traveler device is currently not commercially available in the us; however, it is similar to a device sold in the us.
 
Event Description
It was reported that the procedure was to treat a moderately tortuous, heavily calcified eccentric de novo lesion in the distal right coronary artery (rca). The 1. 5x15mm rx traveler balloon dilatation catheter (bdc) was advanced to the lesion; however, the balloon ruptured during the third inflation at 10 atmospheres (atm). The device was replaced with a non-abbott balloon which inflated and dilated the lesion. The 3. 0x15mm rx traveler was advanced; the balloon was inflated to 10 atm and then 14 atm; however, the balloon could not dilate the lesion enough due to the heavy calcification. Resistance was noted during advancement and retraction of both rx traveler devices due to interactions with the anatomy. A 3. 0x28 xience was deployed and post-dilatation was performed with a non-abbott balloon to complete the procedure. There was no clinically significant delay in the procedure and no adverse patient effects. No additional information was provided.
 
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Brand NameTRAVELER RX 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 Key6832317
MDR Text Key84329271
Report Number2024168-2017-07131
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K103110
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
Report Date 08/30/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/30/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2019
Device Catalogue Number1013069-15
Device Lot Number60908G1
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 Received08/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2016
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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