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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR NC TREK RX CORONARY DILATATION CATHETER

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ABBOTT VASCULAR NC TREK RX CORONARY DILATATION CATHETER Back to Search Results
Model Number 1012454-15
Device Problems Deflation Problem (1149); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/02/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Exemption number e2019001. 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 performed to treat a lesion in the right circumflex coronary artery. An unspecified stent was implanted, and the 4. 5x15mm nc trek balloon dilatation catheter (bdc) was used for post-dilatation once at 14 atmospheres, but the balloon only partially deflated after inflation. With force, the bdc was removed along with an unspecified guiding catheter. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
Visual and dimensional inspections were performed on the returned device. The reported deflation issue and difficulty removing the device from the guiding catheter could not be replicated in a testing environment due to the condition of the returned device. 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 and/or complaints from this lot. The account reported that force had to be use to remove the device. 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. The investigation was unable to determine a conclusive cause for the reported deflation issue. The reported difficulty removing the device appears to be related to circumstances of the procedure as the balloon was attempted to be removed partially inflated since deflation could not be achieved. 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 report, the following information was received: returned goods lab identified a separation in the inner member of the device. Although the customer did not notice the separation at any point, it has been confirmed that no portion of the device remains in the patient anatomy. No additional information was provided.
 
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Brand NameNC TREK RX
Type of DeviceCORONARY DILATATION CATHETER
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
MDR Report Key9494972
MDR Text Key178124658
Report Number2024168-2019-14739
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
PMA/PMN Number
K103153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2022
Device Model Number1012454-15
Device Catalogue Number1012454-15
Device Lot Number90524G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/28/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2020
Is This a Reprocessed and Reused Single-Use Device? No

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