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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 1012274-20
Device Problems Difficult To Position (1467); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/11/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Medical devices: guide catheter: boston scientific 6f cl3. 5, dilatation catheters: 3. 0 x 20 mm trek, stent: 2. 5 x 8 mm xience sierra. (b)(4). The device was not returned for evaluation. Investigation is not yet complete. A follow-up will be submitted with all relevant information. The additional trek rx and xience sierra devices are being filed under separate medwatch reports.
 
Event Description
It was reported that the procedure was to treat a moderately tortuous, bifurcation lesion in the diagonal and mid left anterior descending (lad) artery with 80% stenosis. The 2. 5 x 8 mm xience sierra drug eluting stent was deployed in the lad. Plaque shift occurred closing off the diagonal artery during stent deployment. Kissing balloon technique was performed for post dilatation with two 3. 0 x 20 mm trek balloon dilatation catheters (bdc) to open the stent struts of the xience and improve the blood flow in the diagonal. The first 3. 0 x 20 trek was advanced to the lad and the second 3. 0 x 20 trek was placed in the diagonal artery. Resistance had been met with the guiding catheter during advancement of both treks. Both balloons were inflated to 12 atmospheres and negative pressure was held 4 seconds to deflate the balloons. During removal of the second trek bdc, strong resistance was met as the balloon was only partially deflated. Force was used to remove the bdc and the shaft separated. The decision was made to inflate the other trek balloon to assist in removing the separated trek shaft, but resistance with the guide catheter was also met with this trek. All the devices were removed as a unit. A new guide catheter and balloon catheters were used to complete the procedure. The outcome was not as good as they had hoped because the diagonal vessel became occluded, but the patient is doing well. No additional information was provided.
 
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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 Key7507804
MDR Text Key108161792
Report Number2024168-2018-03501
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K103110
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,Followup
Report Date 06/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2020
Device Catalogue Number1012274-20
Device Lot Number80131G1
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 Received06/25/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2018
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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