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

Model Number 2777

Device Problems Detachment of Device or Device Component (2907); Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/14/2024

Event Type  Injury  

Event Description

It was reported that the wire sheared off and the tip detached which remained in the body.The stenosed target lesion was located in the moderately tortuous and moderately calcified mid proximal septal of the left anterior descending artery.During the procedure, a 185cm pt2 guidewire sheared off and the tip detached.The wire was pulled, and an unsuccessful attempt was made to retrieve the guidewire tip.The user was not able to access the device tip; it was noted that there was a stent in the way, and the tip of the device was left in the small septal.The procedure was completed, and the patient was stable.

• Brand Name: PT
• 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: 18862862
• MDR Text Key: 337181777
• Report Number: 2124215-2024-12980
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08714729471196
• UDI-Public: 08714729471196
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030617
• 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: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2777
• Device Catalogue Number: 2777
• Device Lot Number: 0032881772
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2023
• 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; Other