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

Catalog Number 1012446-12

Device Problems Leak/Splash (1354); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/16/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number (b)(4)-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.(b)(4).The device was received.The 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 performed to treat a 90% stenosed, mildly tortuous, and moderately calcified lesion in the distal right coronary artery.A 2.25x12mm nc trek rx balloon dilatation catheter (bdc) was prepared per the instructions for use.The bdc was advanced, dilated the lesion once, and was removed.Upon removal the shaft was noted to be kinked at 10 cm from the proximal edge.Intravascular ultrasound showed insufficient inflation and additional dilatation was needed.The bdc was advanced again; however, resistance was felt and it is unknown if it was with the anatomy or another device.The bdc was being inflated and blood was noted in the indeflator.An attempt to remove the bdc was made, but the proximal shaft separated at 10cm from the proximal edge.The proximal portion of the bdc was withdrawn and the distal separated portion was removed with a double lumen catheter.The procedure was successfully completed with a 2.25x8mm nc trek rx bdc and deployment of an unspecified stent.There were no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001.Visual inspection was performed on the returned device.The reported kink and separation were confirmed.The reported difficulty advancing the device and leak could not be replicated in a testing environment due to the condition of the returned device.It should be noted that the coronary dilatation catheters, nc trek rx, global, instruction for use (ifu), states: do not use, or attempt to straighten, a catheter if the shaft has become bent or kinked; this may result in the shaft breaking.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/complaints from this lot.The investigation determined the reported kink appears to be related to operational context; however, the reported difficulty advancing the device, separation and leak appear to be related to user error.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of this device.

• Brand Name: NC TREK RX
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8976539
• MDR Text Key: 156963435
• Report Number: 2024168-2019-11592
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648151699
• UDI-Public: 08717648151699
• Combination Product (y/n): N
• PMA/PMN Number: K103153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 1012446-12
• Device Lot Number: 90308G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Date Manufacturer Received: 09/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention