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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 1012453-08T
Device Problems Difficult To Position (1467); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/06/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Concomitant medical products: guide wire: sion blue; guide catheter: mach 1 6fr bl3. 5. The device was not returned for analysis. 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 identified no other incidents from this lot. Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device. The investigation determined the reported difficulties appear to be related to circumstances of the procedure. The nc (b)(4) balloon 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.
 
Event Description
It was reported that the procedure was to treat a de novo and eccentric lesion located in the heavily calcified, moderately tortuous, 75% stenosed proximal left anterior descending artery. During attempted advancement of the 4. 0 x 8 mm nc (b)(4) balloon dilatation catheter, the balloon catheter became stuck with the guiding catheter and the balloon catheter shaft became kinked. Resistance was also felt during removal of the balloon catheter from the guiding catheter. Additionally, it was stated that the kink could have occurred prior to use; however, this was not confirmed. No adverse patient effects or clinically significant delay in the procedure were reported. No additional information was provided.
 
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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 Key6038291
MDR Text Key57802862
Report Number2024168-2016-07045
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
Type of Report Initial
Report Date 10/18/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/18/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2019
Device Catalogue Number1012453-08T
Device Lot Number60502G1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/06/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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