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

Catalog Number UNK NC TREK RX / TRAVELER RX

Device Problem Deflation Problem (1149)

Patient Problem No Patient Involvement (2645)

Event Date 01/15/2020

Event Type  malfunction  

Manufacturer Narrative

Occupation: regulatory compliance manager.Abbott vascular recall listna - (b)(4).

Event Description

On january 15, 2020, the abbott vascular determined that a field safety corrective action is required for specific lots of nc trek rx coronary dilatation catheter and nc traveler coronary dilatation catheter.The field action is anticipated to be initiated prior to the end of january 2020.This action is being taken as a result of an increase in the complaint trend for reported failures of deflation for nc trek rx and nc traveler rx coronary dilatation catheter.Product from identified lots may exhibit slow, partial or failure to deflate.The part numbers and lot numbers affected are attached.Potential patient adverse effects as a result of this issue include air embolism, additional intervention, thrombosis, and myocardial infarction.There have been no reports of patient death associated with this issue.However, additional intervention such as surgery could lead to post-operative complications which include death.

Manufacturer Narrative

E3: occupation: regulatory compliance manager.This incident is being associated with a product quality issue related to manufacturing issues associated with deflation issues for nc trek rx and nc traveler rx.A review of the lot history record and complaint history could not be conducted because this event is not related to a specific part and lot number.The complaint investigation determined the reported deflation issues are related to a product quality deficiency with respect to the manufacture.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

Event Description

On (b)(6) 2020, the av tier ii escalation evaluation panel determined that a field safety corrective action is required for specific lots of nc trek rx coronary dilatation catheter and nc traveler coronary dilatation catheter.The field action is anticipated to be initiated prior to the end of (b)(6) 2020.This action is being taken as a result of an increase in the complaint trend for reported device code 1149 ¿deflation¿ for nc trek rx and nc traveler rx coronary dilatation catheter.Product from identified lots may exhibit slow, partial or failure to deflate.The part numbers and lot numbers affected are listed below.Potential patient adverse effects as a result of this issue include air embolism, additional intervention, thrombosis, and myocardial infarction.There have been no reports of patient death associated with this issue.However, additional intervention such as surgery could lead to post-operative complications which include death.

Manufacturer Narrative

This report is resubmitted to ensure the enclosed attachment can be easily opened by the fda.E3: occupation: regulatory compliance manager.Attachment: abbott vascular recall listna - attachment: [cn-021747.Docx].

• Brand Name: NC TREK RX / TRAVELER RX
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9604592
• MDR Text Key: 175489022
• Report Number: 2024168-2020-00771
• Device Sequence Number: 1
• Product Code: LOX
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK NC TREK RX / TRAVELER RX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/15/2020
• Initial Date FDA Received: 01/17/2020
• Supplement Dates Manufacturer Received: 04/30/2020; 07/20/2020
• Supplement Dates FDA Received: 05/04/2020; 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1133- 2020
• Patient Sequence Number: 1