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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 Detachment Of Device Component (1104); Difficult To Position (1467)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/11/2016
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 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
A 2. 5x12mm trek balloon dilatation catheter (bdc) was properly soaked and prepped for use, then an attempt was made to advance the bdc along the guide wire. There was resistance during advancement and the shaft of the bdc snapped and separated into 2 pieces. The bdc was not advanced into the patient anatomy, so the bdc was simply unloaded from the guide wire. A new, same-sized trek bdc was used to successfully complete the procedure. There was no adverse patient effect and no clinically significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: the device was returned for evaluation. The reported separation was confirmed. The reported resistance with the guide wire was not tested/confirmed due to the condition of the returned device. Based on visual analysis of the returned device, there is no indication of a product quality issue with respect to manufacture, design or labeling. The investigation was unable to determine a conclusive cause for the reported resistance with the guide wire; however, the shaft separation appears to be related to operational circumstances. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot. Additionally, a review of the complaint history did not indicate a lot specific quality issue. Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling. (b)(4).
 
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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 Key5414262
MDR Text Key37791940
Report Number2024168-2016-00656
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110134
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 03/02/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/05/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2018
Device Catalogue Number1012447-12
Device Lot Number50903G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/09/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/22/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2015
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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