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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 1012274-12
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Stroke/CVA (1770)
Event Date 11/25/2014
Event Type  Injury  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Concomitant medical devices: guide wire: transcend. Sheath: 6 fr flexor. (b)(4). The customer reported the device was discarded. Investigation is not yet complete. A follow up report will be submitted with all relevant information.
 
Event Description
The index procedure date was (b)(6) 2014. The procedure was to treat a severe stenosis of the distal right internal carotid artery. A non-abbott guide wire was advanced toward the target lesion. The lesion was predilated using a 3. 0x12mm trek rx balloon dilatation catheter (bdc). The device was removed and a 3. 0x12mm non-abbott stent delivery system (sds) was advanced toward the target lesion in an attempt to cross the side of the lesion for deployment but failed. The device was removed and a 3. 0x9mm non-abbott sds was advanced toward the target lesion in an attempt to cross the side of the lesion for deployment and again failed. The 3. 0x9mm non-abbott stent dislodged from the balloon and all attempts to retrieve the stent were unsuccessful. A dissection was noted in the right internal carotid artery and partial closure of the internal carotid artery. The procedure was ended and all interventional equipment was removed. Reportedly during the procedure the patient suffered a stroke. No additional information was provided.
 
Manufacturer Narrative
(b)(4). The device was not returned for evaluation. A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided. Based on the case information, a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined. It should be noted that the coronary dilatation catheters (cdc), trek rx instruction for use states: the trek rx coronary dilatation catheters is indicated for: balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion and balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction. There is no indication of a product quality issue with respect 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)
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 Key6191413
MDR Text Key62908472
Report Number2024168-2016-09059
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 01/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1012274-12
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 Received01/17/2017
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: 12/20/2016 Patient Sequence Number: 1
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