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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT NC TREK CORONARY DILATATION CATHETER

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AV-TEMECULA-CT NC TREK CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1012449-15
Device Problems Detachment Of Device Component (1104); Kinked (1339); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/18/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. (b)(4). 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.
 
Event Description
It was reported that the procedure was to treat a 90% stenosed, moderately tortuous, and heavily calcified lesion in the mid right coronary artery. Resistance with the anatomy was felt while advancing a 3. 0x15mm nc trek balloon dilatation catheter (bdc);. When force was applied, the shaft kinked and the distal shaft separated. The separated portion was outside the patient anatomy so it was simply withdrawn. The procedure was successfully completed with a non-abbott bdc. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Visual inspection was performed on the returned device. The reported kink and separation were confirmed; however, the reported failure to advance could not be replicated in a testing environment as it was based on operational circumstances. It should be noted that the nc trek rx coronary dilatation catheters instruction for use states: if resistance is felt, determine the cause before proceeding. Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and/or damage/separation of the catheter. In this case, it is likely that the use of force during advancement of the catheter resulted in the shaft bending/kinking and ultimately separating. 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 of the reported lot did not indicate a lot specific quality issue. The investigation determined the reported kink and shaft separation appear to be related to user error; however, the failure to advance appears to be related to operational context. 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 NameNC TREK CORONARY DILATATION CATHETER
Type of DeviceCORONARY DILATATION CATHETER
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
MDR Report Key7588864
MDR Text Key111020765
Report Number2024168-2018-04373
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
PMA/PMN Number
K110134
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Remedial Action Other
Type of Report Initial,Followup
Report Date 07/24/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2020
Device Catalogue Number1012449-15
Device Lot Number71006G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2018
Is This a Reprocessed and Reused Single-Use Device? No

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