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

Model Number 1012448-12

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2019

Event Type  Injury  

Manufacturer Narrative

Date of event, relevant tests/lab data: estimated date.Exemption number e2019001.The customer reported the device was discarded.Investigation is not yet complete.A follow-up will be submitted with all relevant information.

Event Description

It was reported that an unspecified 2.75x12mm trek balloon dilatation catheter (bdc) was prepped outside the anatomy prior to use, and the contrast mix was omnipaque 300x500.The bdc was inflated to 18 atmospheres; however, it failed to deflate after almost 10 minutes of trying.The balloon was intentionally ruptured using manual inflation with a syringe in order to remove it.There were no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record and complaint history could not be conducted because the lot number was not provided.The investigation was unable to determine a conclusive cause for the reported deflation issue; however, the additional treatment appears to be related to operational context.Factors that may contribute to difficulty deflating the balloon include, but are not limited to, deflation technique, contrast concentration, loose connection with the indeflator, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.E1 country updated from isr to pse.

• 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: 9512442
• MDR Text Key: 174338064
• Report Number: 2024168-2019-14943
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648151811
• UDI-Public: 08717648151811
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1012448-12
• Device Catalogue Number: 1012448-12
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention