MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMPLATZ SUPER STIFF; WIRE, GUIDE, CATHETER

Model Number	39695
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that device entrapment occurred requiring additional intervention.An amplatz super stiff guidewire was selected for use.During the procedure, it was noted that the guidewire became stuck in lesion.Multiple attempts to snare and hybrid operating room procedure were done to remove the device, but all were unsuccessful.The guidewire was cut off and remained inside the patient.The patient was admitted beyond the standard of care and will be transferred to other facility for surgery.
Event or Problem Description
It was reported that device entrapment occurred requiring additional intervention.An amplatz super stiff guidewire was selected for use.During the procedure, it was noted that the guidewire became stuck in lesion.Multiple attempts to snare and hybrid operating room procedure were done to remove the device, but all were unsuccessful.The guidewire was cut off and remained inside the patient.The patient was admitted beyond the standard of care and will be transferred to other facility for surgery.It was further reported that a decision was made by a multidisciplinary team including cardiothoracic surgery to leave the wire in place due to the risk and patient's clinical condition.

• Brand Name: AMPLATZ SUPER STIFF
• 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: 21963430
• Report Number: 2124215-2025-26706
• Device Sequence Number: 7227142
• Product Code: DQX
• UDI-Device Identifier: 08714729114604
• UDI-Public: (01)08714729114604(17)280204(10)35779453
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K843018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2025

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 Model Number: 39695
• Device Catalogue Number: 39695
• Device Lot Number: 0035779453
• 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: 04/11/2025
• Supplement Date Received by Manufacturer: 05/18/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 06/12/2025
• Date Device Manufactured: 02/04/2025
• 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; Required Intervention; Hospitalization
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Race: White