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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 1012451-15
Device Problem Sticking (1597)
Patient Problem Ischemia (1942)
Event Date 04/28/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Correction: patient identifier. Correction: the date received by mfr. Date was filed incorrectly on the initial medwatch report as 12/18/2017, but should have been 11/12/2017. (b)(4).
 
Manufacturer Narrative
Internal file number - (b)(4). The device was not returned for analysis. 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. The investigation was unable to determine a conclusive cause for the reported difficulty removing the balloon; however, the reported patient effect appears 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.
 
Manufacturer Narrative
(b)(4). Concomitant medical devices: dil cath, guide wire; inflation; guide cath; rhv; sheath; atherectomy; power (volts); stent; other electrical; other; vessel closure; embolic protection; clip delivery system. (b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information.
 
Event Description
It was reported that the procedure was to treat the left anterior descending artery. A 3. 0 x 29 mm unspecified stent was implanted; however, it was not well apposed to the vessel wall. Therefore, a 3. 5 x 15 mm nc trek balloon dilatation catheter (bdc) was used for post dilatation. However, the balloon became stuck with the stent struts, which resulted in coronary ischemia. The physician inflated and deflated the balloon repeatedly until the bdc was removed. Another unspecified bdc was then used for dilation. There was no adverse patient sequela reported. 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 Key7196005
MDR Text Key167718320
Report Number2024168-2018-00410
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K110134
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,Followup
Report Date 02/28/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number1012451-15
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/15/2018
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

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