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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 1012449-12
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Intimal Dissection (1333)
Event Date 11/07/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device was not returned for evaluation. A review of the lot history record could not be conducted because the lot number was not provided. The reported patient effect of intimal dissection is listed in the coronary dilatation catheters (cdc), nc trek rx, global, instructions for use (ifu) as a known patient effect. A conclusive cause for the reported patient effect and the relationship to the product, if any, could not be determined and there is no indication of a product quality issue with respect to the design, manufacture or labeling of the device. The 2. 8 x 19 mm graftmaster stent delivery system referenced is filed under a separate manufacturing report number.
 
Event Description
It was reported that the patient underwent a coronary stenting procedure, treating severe calcification of the entire proximal to mid to distal right coronary artery (rca). Rotational atherectomy was performed and a perforation was noted in the mid rca. A trek balloon dilatation catheter was advanced to the perforation and inflated, with an improvement in extravasation; however, extravasation continued. A 2. 75 x 12 mm xience alpine stent was implanted just distal to the perforation and a 2. 8 x 19 mm graftmaster stent delivery system (sds) was advanced; however, blood was noted in the inflation line and a balloon tear was noted, possibly from vessel plaque and calcification or possibly from stent struts of a previously implanted stent. The graftmaster sds was removed from the anatomy without difficulty. Additional pre-dilatation was performed using a 3. 0 x 12 mm nc trek, and a dissection occurred. An nc trek was then advanced to the dissection and inflated, treating the dissection and further dilating the vessel. A 3. 5 x 19 mm graftmaster was then deployed, sealing the perforation. Post dilatation was performed and additional stents implanted. Final angiography noted no residual stenosis and no evidence of a dissection. No additional information was provided.
 
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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 Key7065188
MDR Text Key93162875
Report Number2024168-2017-09206
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110134
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 11/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1012449-12
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 Received11/15/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/28/2017 Patient Sequence Number: 1
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