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

Model Number 1012453-15

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number e2019001. The device was received. Investigation is not yet complete. A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was performed to treat an 80% stenosed, heavily tortuous, and heavily calcified lesion in the right coronary artery. Following pre-dilatation, a 3. 5x33mm xience sierra stent was deployed without issues. A 4. 0x15mm nc trek balloon dilatation catheter (bdc) was used to post-dilate the stent at nominal pressure; however, the balloon would not deflate. An attempt to deflate the balloon with a second indeflator was made, but this too failed. The balloon was inflated to 20 atmospheres and a non-abbott guide wire was advanced and ruptured the balloon. The bdc was able to be retrieved. There were no adverse patient sequela and no clinically significant delay in the procedure. No additional information was provided.

• 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: 9512115
• MDR Text Key: 176404497
• Report Number: 2024168-2019-14937
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648152078
• UDI-Public: 08717648152078
• 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

Reporter Occupation

• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 03/25/2020

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

• Device Expiration Date: 07/31/2022
• Device Model Number: 1012453-15
• Device Catalogue Number: 1012453-15
• Device Lot Number: 90828G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/23/2019 Patient Sequence Number: 1