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

Model Number 1012453-20

Device Problems Deflation Problem (1149); Material Rupture (1546)

Patient Problems Death (1802); Occlusion (1984); Perforation (2001)

Event Date 01/23/2020

Event Type  Death  

Manufacturer Narrative

The customer reported the device was discarded. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information. 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 safety action number is 2024168-1/27/2020-001. 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.

Event Description

It was reported that on (b)(6) 2020, the patient presented with an st elevated myocardial infarction. A percutaneous coronary intervention was initiated on the left anterior descending (lad), moderately calcified lesion. An nc trek (1012453-20, 90923g1) dilatation catheter advanced to the lesion site and inflated without reported issues. Deflation was attempted; however, the balloon was unable to deflate. As troubleshooting, the balloon was re-inflated. The balloon had then ruptured and the lad perforated. A covered stent was implanted as treatment. The diagonal coronary artery then ¿shut down¿. Pericardiocentesis was performed. On (b)(6) 2020, the patient had expired while in critical care. No additional information as provided regarding this issue.

• Brand Name: NC TREK RX
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 9727825
• MDR Text Key: 180004055
• Report Number: 2024168-2020-01609
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 1012453-20
• Device Catalogue Number: 1012453-20
• Device Lot Number: 90923G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1133-2020

Patient Treatment Data

Date Received: 02/19/2020 Patient Sequence Number: 1