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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 1012451-15
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 04/25/2016
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 is expected to be returned for investigation. 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 a lesion in the proximal circumflex artery with mild tortuosity and mild calcification. A 3. 5x15mm nc trek rx balloon dilatation catheter (bdc) was advanced and resistance was noted with an unspecified guide catheter. The trek was pushed and the proximal shaft separated. There was no adverse patient effect and no clinically significant delay in the procedure.
 
Manufacturer Narrative
(b)(4). The device was not returned for evaluation. 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. It should be noted coronary dilatation catheters nc trek rx, global 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. 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. 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.
 
Event Description
Subsequent to filing the initial mdr, additional information received indicates that the separated catheter was removed with the guide catheter as a single unit. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Correction: subsequent to the previous report, the device was returned and the evaluation has been completed. Evaluation summary: visual and dimensional inspections were performed on the returned device. The reported separation and torn material were 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. The reported tear in the shaft appears to be related to circumstances of the procedure. It should be noted coronary dilatation catheters (cdc), nc trek rx, global, 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. 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. 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.
 
Event Description
Subsequent to filing the previous report the following additional information was received: the separated catheter was removed with the guide catheter as a single unit.
 
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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 Key5667188
MDR Text Key45577666
Report Number2024168-2016-03249
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeLE
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,Followup
Report Date 08/24/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2019
Device Catalogue Number1012451-15
Device Lot Number60224G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/29/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/23/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2016
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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