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

Model Number 1012276-20

Device Problems Off-Label Use (1494); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/21/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number e2019001. (b)(4). The device is expected to be returned for investigation. It has not yet been received. A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a left femoropopliteal bypass artery. After successful use of an armada balloon dilatation catheter, the trek rx balloon was advanced without resistance, but wrapped around a 0. 014 sparta core wire and the tip of the balloon separated. The devices were removed without resistance. Snaring of the separated portion was attempted, but unsuccessful and the separated portion was left free-floating in the anatomy. A right groin angiogram was performed and showed good flow with no flow limitation to the common femoral artery in the right groin. Patient was transferred to recovery area in stable condition with no complaint of pain or discomfort. The patient will undergo ultrasound in the coming weeks to ensure that there is no limiting flow and to ensure that the patient is not experiencing any adverse effects. No additional information was provided.

• Brand Name: TREK RX CORONARY DILATATION CATHETER
• 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: 9468774
• MDR Text Key: 175023761
• Report Number: 2024168-2019-14526
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/31/2022
• Device Model Number: 1012276-20
• Device Catalogue Number: 1012276-20
• Device Lot Number: 90408G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2019
• 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: 12/13/2019 Patient Sequence Number: 1