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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 1012450-15T
Device Problems Difficult To Position (1467); Difficult to Remove (1528)
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. Concomitant products: guide wire: glandslam. Guide catheter: launcher 6f ebu. The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all relevant information. The tenku dilation catheter device is an abbott vascular manufactured device which is distributed in by (b)(4). Though 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 moderately calcified, eccentric, de novo, 75% to 95% stenosed, 15mm-long lesion in the moderately tortuous, 2. 5mm-diameter, proximal to the distal left circumflex (lcx) coronary artery. When advancing a 3. 25x15 nc tenku rx balloon dilatation catheter (bdc) over the proximal end of a grandslam guide wire (gw), while still outside of the patient anatomy, resistance was felt between the two devices. The bdc with withdrawn from the gw with resistance felt and the gw was wiped with saline-soaked gauze. The bdc was then re-advanced over the gw, however, as the bdc was advanced into the coronary vessel, resistance increased. Thus, the uninflated bdc was retracted over the gw and out of the anatomy, with resistance felt against the proximal gw. The same guide wire was able to be used with a non-abbott bdc and a non-abbott stent delivery system without issue to complete the procedure. There were no adverse patient effects and no occurrence of a clinically significant delay. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: visual, dimensional and functional inspections were performed on the returned device. The reported resistance with the guide wire was not 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 identified no other incidents from this lot. The investigation was unable to determine a conclusive cause for the reported difficulties as there was no resistance noted with the guide wire during returned analysis. 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 Key6201094
MDR Text Key63475782
Report Number2024168-2016-09194
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 02/07/2017
1 Device was Involved in the Event
1 Patient was 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 Date12/31/2018
Device Catalogue Number1012450-15T
Device Lot Number60104G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/16/2017
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 Manufactured01/01/2016
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: 12/22/2016 Patient Sequence Number: 1
Treatment
CONCOMITANT MEDICAL DEVICES
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