MAUDE Adverse Event Report: AV-TEMECULA-CT TREK CORONARY DILATATION CATHETER

Device Problems Improper or Incorrect Procedure or Method (2017); Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/14/2019

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 customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional nc trek device referenced is being filed under a separate medwatch report.

Event Description

It was reported that an nc trek and a trek balloon dilatation catheter were used to successfully complete the procedure.After the procedure, it was noted that the balloon dilatation catheters did not have the size stamped on the devices.The size stamp was completely missing from the hub of both balloon dilatation catheters.There was no reported clinically significant delay in the procedure and no adverse patient sequela.No additional information was provided.

Manufacturer Narrative

Internal file number (b)(4).Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated.The device was not returned for evaluation.It should be noted that the coronary dilatation catheters (cdc), trek rx and mini trek rx, global, information for use, states: prior to angioplasty, the dilatation catheter should be examined to verify functionality and ensure that its size is suitable for the specific procedure for which it is to be used.A review of the lot history record and complaint history could not be conducted because the part and lot numbers were not provided.The investigation determined the reported device marking issue appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

• Brand Name: TREK CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8595220
• MDR Text Key: 144569819
• Report Number: 2024168-2019-03692
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1