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

Model Number	40295
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the guidewire could not be separated from other devices.A.018/260cm platinum plus guidewire was selected for treatment.During the procedure, it was noted that the physician was unable to separate the sheath, wire, and a non-boston scientific (bsc) sensor from each other.The wire did not have the support to bring the sensor forward to the pulmonary artery, so the physician tried to pull the device back through the sheath.The sheath folded over on itself.The physician determined they could not safely remove the sheath or the sensor, so the site's vascular surgery came to assist.Vascular team was able to pull the sheath out, but the sensor remained in the patient's soft tissue.A small cut was performed which allowed the sensor to be removed.Patient remained stable throughout the entire procedure, and the patient was discharged and not hospitalized following the procedure.There were no post-procedure complications, but the physician reported there to be a significant delay due to deciding the plan of action and waiting for the vascular team to arrive.
Event or Problem Description
It was reported that the guidewire could not be separated from other devices.A.018/260cm platinum plus guidewire was selected for treatment.During the procedure, it was noted that the physician was unable to separate the sheath, wire, and a non-boston scientific (bsc) sensor from each other.The wire did not have the support to bring the sensor forward to the pulmonary artery, so the physician tried to pull the device back through the sheath.The sheath folded over on itself.The physician determined they could not safely remove the sheath or the sensor, so the site's vascular surgery came to assist.Vascular team was able to pull the sheath out, but the sensor remained in the patient's soft tissue.A small cut was performed which allowed the sensor to be removed.Patient remained stable throughout the entire procedure, and the patient was discharged and not hospitalized following the procedure.There were no post-procedure complications, but the physician reported there to be a significant delay due to deciding the plan of action and waiting for the vascular team to arrive.It was further reported that this compliant was reported via medwatch number mw5165238.

• Brand Name: PLATINUM PLUS
• 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; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21395766
• Report Number: 2124215-2025-06964
• Device Sequence Number: 8292180
• Product Code: DQX
• UDI-Device Identifier: 08714729326212
• UDI-Public: 08714729326212
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K945379
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2025

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: 09/04/2026
• Device Model Number: 40295
• Device Catalogue Number: 40295
• Device Lot Number: 0032361053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2025
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 03/07/2025
• Date Device Manufactured: 09/05/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: IMPLANTABLE MICROSENSOR SYSTEM - CARDIOMEMS; IMPLANTABLE MICROSENSOR SYSTEM - CARDIOMEMS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown