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

Model Number 2781

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Obstruction/Occlusion (2422); Foreign Body In Patient (2687)

Event Date 02/07/2024

Event Type  Injury  

Event Description

It was reported that tip detachment occurred, and device fragment remained in patient.The patient underwent percutaneous coronary intervention (pci).The 90% stenosed target lesion was located in the moderately tortuous and severely calcified right coronary artery (rca).A 300cm moderate support straight pt guidewire was advanced into the lesion.However, during the procedure with difficult manipulation, the tip of the guidewire fractured inside the proximal right coronary artery (rca).The 2-3cm tip of the device remained inside the patient body since it could not be removed.The patient was supposed to have blood vessel occlusion treated with medicine and will be transferred to a higher-levelled hospital for further treatment.

Manufacturer Narrative

E1 initial reporter phone: (b)(6).

• 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: 18869285
• MDR Text Key: 337257823
• Report Number: 2124215-2024-13793
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08714729471233
• UDI-Public: 08714729471233
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K030617
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2781
• Device Catalogue Number: 2781
• Device Lot Number: 0031409383
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2023
• 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): Other
• Patient Age: 61 YR
• Patient Sex: Male