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

Model Number	39895
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guidewire tip detachment and un-retrieved device fragment occurred.During a cardiomems implant procedure, a 018/260cm platinum plus guidewire was used and positioned.However, it was noted that the tip of the guidewire was pointing back down the length of the wire rather than down the arterial branch.When the guidewire was pulled back into the cardiomems delivery catheter the distal 3cm of the guidewire sheared off and remained in the patient.The procedure was completed with this device.Heparin was administered and the patient was retained overnight for observation.No further patient complications were reported.The patient was discharged the following day.
Event or Problem Description
It was reported that guidewire detachment occurred, requiring intervention.A non-boston scientific (bsc) product was advanced for implant.During the procedure, a 018/260 platinum plus guidewire broke inside the patient.The size of the piece was approximately 5mm in length.The break was noticed after sensor deployment as the physician was removing the wire and delivery catheter from the patient.A snare was used to remove the broken piece.There were no adverse consequences to the patient and no additional intervention required.
Additional Manufacturer Narrative
B5.Event description, d.Suspect medical device, e.Initial reporter, and h6.Patient, impact and device codes were updated per additional information.

• Brand Name: PLATINUM PLUS
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15421846
• Report Number: 2124215-2022-33474
• Device Sequence Number: 6526335
• Product Code: DQX
• UDI-Device Identifier: 08714729326212
• UDI-Public: 08714729326212
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K935997
• 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): 09/16/2022

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: 05/01/2025
• Device Model Number: 39895
• Device Catalogue Number: 39895
• Device Lot Number: 0029321276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2022
• Supplement Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2022
• 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: Required Intervention
• Patient Sex: Unknown