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

Catalog Number 1012451-15

Device Problems Inflation Problem (1310); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2019

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.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that during a percutaneous coronary intervention, while advancing the nc trek over the guide wire, the shaft was observed to have a slight bend.It was not possible to pull negative pressure with the inflation device.At that point, it was noted that the shaft separated into two pieces while still inside the tip of the guide.The balloon was not progressed past the end of the guide catheter.The separated portion was snared using another guide wire and the entire device was removed as a unit.There was no reported adverse patient effect or a clinically significant delay in procedure.The procedure was completed using a new guide wire and balloon.Although there was a delay reported, it was not clinically significant.No additional information was provided.

Manufacturer Narrative

Visual inspection was performed on the returned device.The reported separation was confirmed.The reported bent was not confirmed; however, it is likely that the bent reported was located at the separated location noted during return analysis.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 of the reported lot did not indicate a lot specific quality issue.It was reported that the account noted the bend on the shaft and attempted to pull negative, but it was unsuccessful as the shaft had separated.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use 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.The investigation determined the reported bent appears to be related to operational context; however, the shaft separation appears to be related to user error.It is likely that the attempt to continue to use the device after the bent was noted resulted in the shaft ultimately separating.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.H6: device code 1310 - removed.

• 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: 9083837
• MDR Text Key: 161218021
• Report Number: 2024168-2019-11886
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648151989
• UDI-Public: 08717648151989
• 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: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 1012451-15
• Device Lot Number: 90626G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Date Manufacturer Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 100