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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 1012453-12T
Device Problems Kinked (1339); Difficult To Position (1467); Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/23/2016
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 balloon dilation catheter is an abbott vascular manufactured device which is distributed in (b)(6) by st. Jude medical (b)(4) company, ltd. 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 concentric de novo lesion located in the proximal to mid left anterior descending artery that had mild tortuosity, moderate calcification and was 90% stenosed. The 4. 0 x 12 mm nc tenku was being advanced for post dilatation of a deployed stent. Resistance was felt with the inner lumen of the guiding catheter (gc) during advancement, until it stopped advancing. The nc tenku was removed and the proximal and mid catheter shaft were found kinked. A new balloon catheter was used and the procedure was completed with kissing balloon technique (kbt). There was no reported clinically significant delay in the procedure. There was no adverse patient effect. No additional information was provided. Return device analysis revealed a tear in the guide wire exit notch.
 
Manufacturer Narrative
(b)(4). Evaluation summary: (b)(4). Visual inspection was performed on the returned device. The reported kink was confirmed. Additionally, the distal shaft was torn at the guide wire exit notch. The reported difficulty to be positioned could not be replicated in a testing environment due to the condition of the returned device. The investigation was unable to determine a conclusive cause for the reported difficulty to remove; however the kinked shaft 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 identified no other similar 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.
 
Event Description
Subsequent to filing the initial report, the following information was received: the 4. 0 x 12 mm nc tenku was successfully advanced for post dilatation of a deployed stent for one inflation at 10 atmospheres using kissing balloon technique (kbt). When the nc tenku was being withdrawn/pulled into the guiding catheter (gc), the nc tenku met resistance with the inner lumen of the gc. 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 Key5663768
MDR Text Key45448710
Report Number2024168-2016-03209
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 06/09/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/18/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2016
Device Catalogue Number1012453-12T
Device Lot Number40505G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/07/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/01/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2014
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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