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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 1012451-20
Device Problems Detachment Of Device Component (1104); Kinked (1339); Difficult To Position (1467); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/05/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information. (b)(4) the device was received. Investigation is not yet complete. A follow up report will be submitted with all relevant information.
 
Event Description
It was reported the procedure was to treat a heavily tortuous and calcified lesion in the circumflex (cx) artery. The 3. 50x20mm nc trek balloon catheter was noted to be kinked prior to use however was advanced in the guiding catheter. Resistance was met during advancement and retraction in the guiding catheter and the hypotube separated. The proximal portion was removed from the guiding catheter however the distal portion was still inside therefore a 2. 5mm rx trek balloon catheter was advanced to assist in retrieving the 3. 50 nc trek. All the devices were removed as a system. Another 3. 5mm nc trek was used to complete the procedure. 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 and dimensional inspections were performed on the returned device. The reported kink and separation were confirmed. The reported difficulty to position and difficulty removing the device could not be replicated in a testing environment due to the condition of the returned device. 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 determined the reported difficulty positioning and retracting the device and separation appear to be related to user error; however, the reported kink and additional treatment appear to be related to operational context. It should be noted the nc trek instructions for use (ifu) states: prior to use examine all equipment carefully for defects. Examine the dilatation catheter for bends, kinks, or other damage. Do not use any defective equipment. Additionally, the warning section of the ifu states: do not use, or attempt to straighten, a catheter if the shaft has become bent or kinked; this may result in the shaft breaking. It is possible that the ifu violations caused and contributed to the reported difficulties. There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
 
Event Description
Subsequent to the initially filed medwatch report additional information was received stating the physician kinked the shaft and attempted to straighten it out. No additional information was provided.
 
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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
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 Key7626140
MDR Text Key111915685
Report Number2024168-2018-04780
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110134
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 08/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2021
Device Catalogue Number1012451-20
Device Lot Number80409G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/14/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/02/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2018
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: 06/21/2018 Patient Sequence Number: 1
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