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

Model Number	39695
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the wire entrapment occurred.A 75cm.035 amplatz super stiff guidewire was selected for use.During the procedure, the wire tip became entrapped in the tricuspid valve and was unable to be retrieved from the patient.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
B3: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported via attached voluntary medwatch report # mw5169135 that wire entrapment occurred.A 75cm.035 amplatz super stiff guidewire was selected for use.During the procedure, the wire tip became entrapped in the tricuspid valve and was unable to be retrieved from the patient.There were no patient complications as a result of this event.It was further reported that due to the patient pre-existing condition and the high risk associated with open-heart surgery, the decision was made to leave the wire in place and monitor the patient closely.
Additional Manufacturer Narrative
B5: the event description has been updated to reflect that this is a medwatch report.A2: age at time of event: additional info a3a and b: sex and gender: additional info a5: ethnicity: additional info b3: date of event: updated date b7: other relevant history: additional info e1: initial reporter title, initial reporter first name, initial reporter last name, initial reporter phone, initial reporter email, occupation: additional info e4: init rptr also sent rep to fda: updated g2: report source: added user facility.

• 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: 22009622
• Report Number: 2124215-2025-28196
• Device Sequence Number: 14759676
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 04/14/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 05/29/2025
• 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
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic