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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 1012447-12
Device Problems Device Operates Differently Than Expected (2913); Torn Material (3024)
Patient Problem No Patient Involvement (2645)
Event Date 07/27/2017
Event Type  malfunction  
Manufacturer Narrative
Internal file number - (b)(4). Evaluation summary: visual inspection was performed on the returned device. The reported torn material (balloon) was not confirmed and the reported device operated differently (noise) could not be replicated in a testing environment as it was based on operational circumstances. 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 other similar incidents from this lot. The investigation was unable to determine a conclusive cause for the reported difficulties. 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. Estimated date of event. The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all additional relevant information.
 
Event Description
It was reported that before use when the protective sheath was removed from the nc trek rx 2. 5 x 12 mm balloon dilatation catheter there was no difficulty or resistance; however, the balloon made a bursting noise and the balloon looked burst although it was not touched. The device was not used in the patient anatomy. The procedure was completed using another unspecified balloon. There was no reported adverse patient effect. There was no reported clinically significant delay in the procedure. 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)
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 Key6807595
MDR Text Key186016114
Report Number2024168-2017-06818
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeGM
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 09/18/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2019
Device Catalogue Number1012447-12
Device Lot Number60505G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/21/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2016
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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