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

Model Number	39935
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulty and guidewire detachment occurred.The patient underwent cardiomems implant procedure.After completing the right heart catheterization, conducting an angiogram of the vessels on the left side and finding a target area, a 3 018/260 platinum plus guidewire was inserted.The delivery catheter was then advanced over the wire.However, it was decided that the devices were too distal from the desired location.The delivery catheter was pulled back and the devices appeared to jump back up to the arch.The wire was able to be moved back to the desired position without difficulty.It was noted that the wire felt a little "sticky" inside the delivery system but seemed to be okay.The sensor was then deployed in the target area and calibrated with no issues.During withdrawal, it was noted that the guidewire was slow to be removed but was eventually removed.Upon visual inspection, the guidewire appeared to have been pulled apart.No material was thought to have been left in the patient and the physician did not believe the delivery catheter was at fault.No patient complications were reported and the patient condition was stable.

• 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: 15467866
• Report Number: 2124215-2022-34188
• Device Sequence Number: 19950415
• Product Code: DQX
• UDI-Device Identifier: 08714729114574
• UDI-Public: 08714729114574
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 09/21/2022

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 Expiration Date: 05/30/2025
• Device Model Number: 39935
• Device Catalogue Number: 39935
• Device Lot Number: 0029503677
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 09/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2022
• 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
• Patient Sex: Unknown