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U.S. Department of Health and Human Services

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

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AV-TEMECULA-CT NC TENKU DILATATION CATHETER CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1012451-15T
Device Problem Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/08/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The nc tenku dilation catheter device is an abbott vascular manufactured device which is distributed in (b)(4). Although this device is not commercially available for sale in the us, it is similar to a device currently marketed for sale in the us. 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
It was reported that the procedure was to treat a 90% stenosed, mildly tortuous, and mildly calcified de novo lesion in the mid left anterior descending artery. A 3. 5x15mm nc tenku balloon dilatation catheter was being used for pre-dilatation; however, the balloon ruptured at 14 atmospheres during the second inflation. No replacement balloon catheter was used for further dilatation and the procedure was successfully completed with an unknown stent deployment. There was no clinically significant delay in the procedure and no adverse patient effects. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary:visual and functional inspections were performed on the returned device. The reported balloon rupture was confirmed. A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint. Additionally, a review of the complaint history did not indicate a lot specific quality issue. The investigation determined the reported balloon rupture appears to be related to circumstances of the procedure. Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
 
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Brand NameNC TENKU 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 Key6201056
MDR Text Key63500428
Report Number2024168-2016-09188
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeJA
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 02/08/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2019
Device Catalogue Number1012451-15T
Device Lot Number60601G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/13/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/03/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2016
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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