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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 1012449-15T
Device Problem Leak/Splash (1354)
Patient Problems Air Embolism (1697); Bradycardia (1751)
Event Date 10/20/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: guide wire: run through ns, guide cath: heartrail jr3. 5. The nc tenku dilation catheter device is an abbott vascular manufactured device which is distributed in (b)(4) by (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 was received. Investigation is not yet complete. 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% restenosis with moderate calcification in the mid right coronary artery. The lesion was pre-dilated with a cutting balloon and a 3. 0x15mm nc tenku balloon dilatation catheter (bdc) was advanced to the lesion; however, when attempting to inflate the balloon to 18 atmospheres the balloon inflated slightly at first, then pressure loss occurred inside the anatomy and bradycardia occurred. Contrast escaping from the balloon was not confirmed under fluoro. The device was removed from the patient and an attempt to inflate the balloon was made; however, it would not inflate. The 3. 0x15mm nc tenku bdc had been prepped outside the anatomy prior to use and there was no issue or leak noted. The bradycardia resolved on its own and the procedure was successfully completed with a new 3. 0x15mm nc tenku bdc and a 3. 0mm drug catheter balloon. The physician suspected air was introduced into the vessel due to a hole in the shaft which caused the bradycardia. There was no clinically significant delay in the procedure. No additionally information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: visual, functional and scanning electron microscopy analysis were performed on the returned device. The reported leak was confirmed. The investigation determined the reported leak and subsequent patient effect 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 of the reported lot 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 the design, manufacture, or labeling of the device.
 
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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 Key6096048
MDR Text Key59737103
Report Number2024168-2016-07891
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 12/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2019
Device Catalogue Number1012449-15T
Device Lot Number60202G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer11/04/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/30/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/11/2016 Patient Sequence Number: 1
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