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

Model Number 1012455-20

Device Problems Deflation Problem (1149); Off-Label Use (1494)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2020

Event Type  Injury  

Manufacturer Narrative

The device is not returning.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 the renal artery.A 5x20mm nc trek balloon dilatation catheter (bdc) completely failed to deflate, so a non-abbott needle device was introduced to puncture and deflate the balloon.Then the balloon was removed.There were no adverse patient sequelae and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

H6: device code 1494-incorrect anatomy.The complaint device was not returned for analysis.A review of manufacturing records could not be conducted because the lot number was not provided.It was reported that the device was used in a renal artery procedure.It should be noted coronary dilatation catheters (cdc), nc trek rx, global, instruction for use (ifu) states: the nc trek rx coronary dilatation catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm - 5.00 mm only).In this case, it is unknown if the reported ifu violation caused or contributed to the reported complaint.Further investigation determined the reported deflation problem is a product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performances of these devices.

• 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: 9642397
• MDR Text Key: 176807091
• Report Number: 2024168-2020-00967
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648152160
• UDI-Public: 08717648152160
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1012455-20
• Device Catalogue Number: 1012455-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MICROPUNCTURE NEEDLE; MICROPUNCTURE NEEDLE
• Patient Outcome(s): Required Intervention