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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 1012273-12
Device Problem Material Rupture (1546)
Patient Problems Angina (1710); Ischemia (1942)
Event Date 08/16/2017
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.
 
Manufacturer Narrative
Internal file number - (b)(4). The device was not returned for evaluation. A review of the lot history record and complaint history of the reported device could not be conducted because the lot number was not provided. The reported patient effect angina as listed in the coronary dilatation catheters trek rx instructions for use is a known patient effect. The investigation was unable to determine a conclusive cause for the reported balloon rupture; however, the reported patient effects appear 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). During processing of this complaint, attempts were made to obtain complete event, patient and device information. (b)(4).
 
Event Description
It was reported that the procedure was to treat an unspecified coronary artery. A 2. 75 x 12 mm trek balloon dilatation catheter (bdc) was used; however, the balloon ruptured. This resulted in insufficient blood flow to the artery and the patient experienced angina. Therefore, the bdc was withdrawn immediately. After the catheter was replaced with another unspecified device the patient improved. There was no adverse patient sequela reported. No additional information was provided.
 
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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 Key7195647
MDR Text Key167718321
Report Number2024168-2018-00408
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCH
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,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 Number1012273-12
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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