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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 1012453-12
Device Problems Detachment Of Device Component (1104); Difficult To Position (1467)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/20/2017
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 additional information.
 
Event Description
It was reported that this was a percutaneous intervention (pci) treating a proximal right coronary artery (rca) heavily calcified lesion. During nc trek advancement over a balance middle weight i (bmw) guidewire, just inside the sheath, resistance was met at a guidewire junction. The nc treks distal shaft separated near the balloon connection. The nc trek and separated portion were removed without issue and without requiring intervention. There were no adverse patient effects and there was no clinically significant delay. There was no additional information provided regarding this device issue.
 
Manufacturer Narrative
(b)(4). Visual, dimensional and functional inspections were performed on the returned device. The reported shaft separation was confirmed; however, the difficulty positioning the device over the guide wire was not confirmed. 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 determined the reported proximal shaft separation appears to be related to circumstances of the procedure; however, a conclusive cause for the reported difficulty positioning the guiding catheter could not be determined. 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
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 Key6588401
MDR Text Key75931682
Report Number2024168-2017-04442
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
Remedial Action Other
Type of Report Initial,Followup
Report Date 06/13/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2019
Device Catalogue Number1012453-12
Device Lot Number70106G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer05/19/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/01/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2017
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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