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

Model Number	2781
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Foreign Body In Patient (2687)
Date of Event	02/07/2024
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
E1 initial reporter phone: (b)(6).

• Brand Name: PT
• Common Device Name: 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
• Report Number: 2124215-2024-13793
• Device Sequence Number: 11532147
• Product Code: DQX
• UDI-Device Identifier: 08714729471233
• UDI-Public: 08714729471233
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K030617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/11/2025
• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2024
• Initial Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR
• Patient Sex: Male