MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LUGE; WIRE, GUIDE, CATHETER

Model Number 2746

Device Problems Detachment of Device or Device Component (2907); Difficult to Advance (2920)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/28/2024

Event Type  Injury  

Event Description

It was reported that tip detachment occurred resulting in un-retrieved device fragment in patient.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.The target lesion was located in the middle and distal left anterior descending artery (lad).The guide and a 182cm luge guidewire were advanced.Due to a large calcium burden, the physician experienced difficulty advancing the guidewire into the distal vessel.Once the wire was in position, the physician used a 2.0mm x 15mm emerge rx balloon catheter to open the lumen area.The balloon was inflated, and it was observed that there was no flow to the distal lad.The physician then used smaller balloons to try to restore flow to the distal vessel and some flow was restored.The balloon and the guidewire were then removed from the vessel.However, upon removal of the wire, the tip was broken and no longer attached to the guidewire.The distal tip of the guidewire remains in the distal lad which was confirmed through x-ray and angiography.There was no attempt made to retrieve the tip of the wire from the patient.At the time of procedure, only balloon angioplasty was performed, and the patient was taken to surgery over the weekend.At the time of reporting, the patient outcome was unknown.

• Brand Name: LUGE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19130810
• MDR Text Key: 340448329
• Report Number: 2124215-2024-21660
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08714729169956
• UDI-Public: 08714729169956
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2746
• Device Catalogue Number: 2746
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2024
• 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
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Race: White