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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT TENKU DILATATION CATHETER CORONARY DILATATION CATHETER

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AV-TEMECULA-CT TENKU DILATATION CATHETER CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1012270-20T
Device Problems Detachment Of Device Component (1104); Kinked (1339)
Patient Problem No Patient Involvement (2645)
Event Date 11/08/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The tenku balloon dilation catheter device is an abbott vascular manufactured device which is distributed in (b)(4) by st. Jude medical (b)(4). Though this device is not commercially available for sale in the u. S, it is similar to a device currently marketed for sale in the u. S. Evaluation summary: visual inspection was performed on the returned device. The hypotube was separated distal to the strain relief tubing. The reported kink was not confirmed; however, it is likely that the kink reported was located at the separated location. In this case, it is possible that the device was inadvertently mishandled during unpackaging such that the device kinked. Kinks or bends in the hypotube can lead to weakening of the hypotube material such that subsequent application of force or further handling can cause a separation. Furthermore, it is likely that the shaft separated at the kink location due to handling during packaging for return of the device to abbott vascular. The investigation was determined that the reported kink appears to be related to circumstances of the procedure. 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. There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
 
Event Description
It was reported that during preparation and before use, when removing the tenku rx balloon dilatation catheter from the dispenser coil, the shaft was kinked. The device was not used in the patient and there was no patient involvement. No additional information was provided. Returned device analysis revealed a hypotube separation.
 
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Brand NameTENKU 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 Key6251161
MDR Text Key65203618
Report Number2024168-2017-00446
Device Sequence Number1
Product Code LOX
UDI-Device Identifier04544881151902
UDI-Public(01)04544881151902(17)180331(10)50406G1
Combination Product (y/n)N
Reporter Country CodeJA
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
Report Date 01/13/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2018
Device Catalogue Number1012270-20T
Device Lot Number50406G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/29/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/16/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2015
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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