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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 1012272-12
Device Problems Difficult To Position (1467); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/30/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Device: above rated burst pressure, failure to follow steps/instructions, incorrect prep. The device is expected to be returned for investigation. It has not yet been received. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat a lesion in the mid left anterior descending coronary artery. A 2. 5x12mm trek rx balloon dilatation catheter (bdc) was prepped prior to use with saline; however, it was not soaked prior to use. The bdc was advanced to the lesion and an attempt to inflate the balloon was made; however, there was no visibility of the balloon inflating on angiography due to the use of saline instead of contrast. Pressure of more than 29 atmospheres was applied and then the balloon ruptured. The procedure was successfully completed with another unknown balloon dilatation catheter. There was no clinically significant delay in the procedure and no adverse patient effects. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Correction: it was initially reported that the device would be returned for analysis. Subsequent information revealed that the device was discarded and is not available for evaluation. The device was not returned for analysis. It was reported that the balloon dilatation catheter (bdc) was inflated to a pressure of more than 29 atmospheres (atm). It should be noted that the warnings section of the trek rx coronary dilatation catheter (cdc), instructions for use (ifu) specifies: balloon pressure should not exceed the rated burst pressure (rbp). The label for the 2. 50x12mm trek rx cdc specifies a rbp of 14 atm. In addition, it was reported that the device was prepped prior to use with saline. It should be noted that the preparation for use section of the ifu specifies: prepare an inflation device with the recommended contrast medium according to the manufacturers instructions. It was also reported that the balloon was not soaked prior to use. It should be noted that the ifu specifies: submerge the balloon in sterile heparinized normal saline during balloon preparation to activate the coating. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history identified no similar incidents from this lot. The investigation determined the reported difficulties appear to be related to the use errors. 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)
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 Key6197221
MDR Text Key63328352
Report Number2024168-2016-09138
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 01/19/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2019
Device Catalogue Number1012272-12
Device Lot Number60905G1
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 Received01/18/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2016
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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