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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 1012270-12T
Device Problems Deflation Problem (1149); Kinked (1339); Difficult to Remove (1528); Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/24/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device was received. Investigation is not yet complete. 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 (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.
 
Event Description
It was reported that the procedure was to treat a moderately tortuous and heavily calcified lesion in the mid right coronary artery. A 2. 0x12mm tenku rx balloon dilatation catheter (bdc) experienced difficulty crossing the calcified lesion; therefore, the bdc was advanced with the support of a guideliner. The bdc reached the lesion and was inflated to 14 atmospheres three times. The balloon deflated without issue after the first 2 inflations. After the third inflation negative pressure was pulled and the bdc was retracted; however, resistance was felt. The whole system was pulled as a single unit and once outside the anatomy it was confirmed that the balloon remained fully inflated. Additionally, it was noticed that the distal shaft was kinked. The lesion was successfully further dilated with a non-abbott balloon catheter. 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, dimensional and functional inspections were performed on the returned device. The reported kink was confirmed; however the deflation issue could not be replicated in a testing environment due to the condition of the returned device. The difficulty to remove and resistance complaints could not be replicated in a testing environment as they are based on operational circumstances. 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 incidents from this lot. The investigation was unable to determine a conclusive cause for the reported deflation issue; however the reported kink, difficulty to remove and physical resistance appear to be related to circumstances of the procedure. There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
 
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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 Key6179703
MDR Text Key62702300
Report Number2024168-2016-08947
Device Sequence Number1
Product Code LOX
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,Followup
Report Date 01/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2018
Device Catalogue Number1012270-12T
Device Lot Number51001G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer12/14/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/12/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2015
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: 12/15/2016 Patient Sequence Number: 1
Treatment
GUIDE WIRE: RUNTHROUGH,SIONBLUEOTHER: GUIDELINER
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