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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 1012449-20
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/29/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device was received. Investigation is not yet complete. 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 right coronary artery. A 3. 00 x 20 mm nc trek rx balloon dilatation catheter (bdc) was selected for the procedure. There were no issues or leaks noted during prep (air aspiration) prior to use. During advancement of the bdc through the guide catheter, the physician attempted to put negative pressure on the balloon with the unspecified inflation device when he noticed that the plunger of the inflation device came back freely (no suction). The physician then noticed that the hub of the bdc had separated from the proximal shaft of the bdc. The bdc was removed from the anatomy and a new unspecified bdc was used to successfully complete the procedure. There was no reported clinically significant delay in the procedure. There was no reported adverse patient sequela. No additional information provided.
 
Manufacturer Narrative
Internal file number -(b)(4). Evaluation summary: the device was returned for analysis and abbott vascular (av) confirmed the reported separation at the hub. Av reviewed the lot history record and there were no manufacturing nonconformities issued to the reported lot that would have contributed to this event. A review of the complaint history identified no other similar incidents reported from this lot. Av conducted root cause analysis and determined the issue may be related to a potential product quality issue. The issue is being addressed per internal operating procedures. Av will continue to trend the performance of these devices.
 
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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)
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 Key7289912
MDR Text Key100915739
Report Number2024168-2018-01311
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCA
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
Report Date 03/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2020
Device Catalogue Number1012449-20
Device Lot Number70816G2
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/20/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/28/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2017
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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