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

Catalog Number	1012446-12
Medical Device Problem Codes	Leak/Splash (1354); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G9: exemption number e2019001-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.H6: device code 2017 - used after damage.The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem 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the bdc was made, but the proximal shaft separated at 10cm from the proximal edge.The proximal portion of the bdc was withdrawn and the distal separated portion was removed with a double lumen catheter.The procedure was successfully completed with a 2.25x8mm nc trek rx bdc and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.
Additional 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
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8976539
• Report Number: 2024168-2019-11592
• Device Sequence Number: 16199681
• Product Code: LOX
• UDI-Device Identifier: 08717648151699
• UDI-Public: 08717648151699
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 08/16/2019
• Supplement Date Received by Manufacturer: 09/21/2019
• Initial Report FDA Received Date: 09/09/2019
• Supplement Report FDA Received Date: 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention