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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 1012272-30
Device Problem Difficult To Position (1467)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/17/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Case description continued: reportedly, both graftmaster stents were implanted with excellent results. Reportedly, there were no adverse patient effects related to use of the trek or the graftmasters. No additional information was provided. Concomitant products: guide wire: runthrough. Guide cath: 8f mb1 launcher. The device was not returned for analysis. A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint. Additionally, a review of the complaint history identified no other incidents from this lot. Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device. The 4. 8x26 rx graftmaster referenced is being filed under a separate manufacturing report number.
 
Event Description
It was reported that during a percutaneous coronary intervention procedure to treat an 80% stenosed, very large and bulky lesion in the ostial and proximal saphenous vein graft (svg) to the right coronary artery (rca), a 2. 5x30 rx trek balloon catheter was advanced over a non-abbott guide wire and through an 8f non-abbott guide catheter, but the trek balloon markers were not able to be visualized under fluoroscopy during advancement. Thus, the 2. 5x30 trek balloon was not inflated and was withdrawn from the anatomy. After withdrawal, the trek balloon markers were confirmed to be present and appeared to be properly crimped in place on the inner member shaft inside the balloon. A 2. 75x30 trek balloon catheter was advanced to the lesion and pre-dilatation was performed. A 4. 8x16 rx graftmaster covered stent was then advanced and deployed in the svg to rca lesion with a maximum inflation pressure of 20 atmospheres (atm) for 20 seconds. A 4. 8x26 graftmaster was then deployed in the lesion with a maximum pressure of 20 atm for 25 seconds, proximal to the implanted 4. 8x16 graftmaster. The use of both graftmaster stents were pre-planned to ensure complete coverage of the bulky, large lesion. As there was minor residual waist in the proximal placed 4. 8x26 graftmaster stent, high pressure post-dilatation was performed using a 5. 0x15 sprinter (non-abbott) balloon for improved stent wall apposition. High pressure post-dilatation was then performed on the distally placed 4. 8x16 graftmaster stent as standard operating procedure, using the same balloon. Stenosis was successfully reduced to less than 10%.
 
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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 Key5568513
MDR Text Key42563486
Report Number2024168-2016-02350
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
Report Date 04/11/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/11/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2018
Device Catalogue Number1012272-30
Device Lot Number51027G1
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 Received03/18/2016
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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