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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 1012451-25
Device Problems Improper or Incorrect Procedure or Method (2017); Component Missing (2306)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/13/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Visual inspection was performed on the returned device. The reported missing balloon markers could not be confirmed as the distal portion of the device was not returned. It was reported that the balloon markers were missing on the device and during follow up the account confirmed that no balloon separation was noted. It should be noted coronary dilatation catheters (cdc), nc trek rx, global, instruction for use 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. 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. The investigation was unable to determine a conclusive cause for the reported missing component (markers). There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
 
Event Description
Subsequently to the previously filed medwatch report, the following additional information was received: there was no resistance during removal of the protective sheath and the device was prepped according to the instructions for use. Physician stated when advancing the nc trek rx in the anatomy he realized there were no radiopaque marks. He removed the balloon under fluoroscopy and he confirmed there were no radiopaque marks. No balloon separation was noted. The device was confirmed to be loaded on the guide wire without any complications. No additional information was provided.
 
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 additional relevant information.
 
Event Description
It was reported that the procedure was to treat an unknown lesion. After the nc trek rx 3. 50 x 25 mm balloon dilatation catheter was advanced to the lesion, but before inflation, it was noticed that there were no radiopaque markers on the balloon. This was confirmed with fluoroscopy after removing the device from the patient. The patient was alternatively treated via percutaneous transluminal medical intervention. There was no reported adverse patient effect. There was no reported clinically significant delay in the procedure. 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 Key6760188
MDR Text Key247004630
Report Number2024168-2017-06338
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K110134
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 09/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2018
Device Catalogue Number1012451-25
Device Lot Number60111G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/07/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/19/2017
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

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