MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number 1012274-30

Device Problems Difficult to Remove (1528); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/20/2021

Event Type  Injury  

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 determined the reported difficulty removing the device, separations, additional treatment, and foreign body in patient appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.User facility medwatch form mw5106318.

Event Description

User facility medwatch report (mw5106318) received stating: when the device was being removed from the patient, it became stuck to an area of calcium in the patient's vessel.Ultimately dislodging the balloon shaft becoming retained.Additionally, it was reported that the 3.00 x 30mm trek balloon dilatation catheter (bdc) was advanced without resistance to the moderately calcified lesion in the profunda artery.The balloon was inflated twice and deflated without issue.During removal, resistance was noted due to calcification in the vessel and the distal shaft, including the balloon separated.Snaring was performed in an attempt to remove the separated portion of the device, but it was not successful, so a bare metal stent was advanced and implanted to secure the separated portion.There was no adverse patient sequela or a clinically significant delay in procedure.No additional information was provided.

• Brand Name: TREK 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: 13573539
• MDR Text Key: 288597986
• Report Number: 2024168-2022-01828
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138461
• UDI-Public: 08717648138461
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1012274-30
• Device Catalogue Number: 1012274-30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention