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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
Device Problems Detachment Of Device Component (1104); Kinked (1339); Difficult To Position (1467); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2012
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device was not returned for analysis. The investigation determined the reported difficulties appear to be related to circumstances of the procedure. A review of the lot history record and complaint history of the reported device could not be conducted because the part and lot number were not provided. 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. There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
 
Event Description
It was reported that resistance was felt when an unknown trek balloon dilatation catheter (dc) was advanced into a guiding catheter and the shaft of the bdc kinked. When the bdc was being removed, resistance was met and the shaft fractured and separated into 2 pieces. It was stated that no adverse patient effects were reported.
 
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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 Key6531988
MDR Text Key74159686
Report Number2024168-2017-03784
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCA
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
Report Date 04/28/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received04/07/2017
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

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