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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 1012449-12
Device Problems Detachment Of Device Component (1104); Difficult To Position (1467); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/06/2016
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 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 lesion located in the left anterior descending coronary artery. The nc trek rx 3 x 12 mm balloon dilatation catheter was prepped and flushed and loaded on the guide wire and while pushing the balloon into the introducer sheath it separated in two pieces outside the anatomy. One end was sticking out of the sheath and the other was in the operator's hand. Slight resistance was noted during advancement. It was also reported that during loading, excessive force was applied on back side. Another balloon was used to complete the procedure. There was no reported adverse patient effect. There was no reported clinically significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: visual and dimensional inspections were performed on the returned device. The reported separation was confirmed. The difficulty to position 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 position; however, the reported shaft separation appears to be related to user error. It should be noted that the nc trek rx, instructions 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. 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. 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.
 
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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 Key6073692
MDR Text Key59335409
Report Number2024168-2016-07485
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 11/22/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/02/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2019
Device Catalogue Number1012449-12
Device Lot Number60721G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer10/20/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/18/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2016
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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