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

Model Number	40295
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: unit returned with overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The returned device matches with upn provided by the customer.The wire returned was inspected and it is possible to observe the spring tip is detached and corewire bent at distal tip.The outer diameter of the middle and proximal sections of the device are within specifications.
Event or Problem Description
Reportable based on device analysis completed on 24-jun-2022.It was reported that guidewire unraveled occurred.The target lesion was located in pulmonary artery.A 018/260cm platinum plus guidewire was advanced; however, during the procedure, the wire unraveled at the tip.The wire was pulled out of the sheath in one piece and there were no patient complications reported.However, returned device analysis revealed distal tip detachment.

• 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: 15015247
• Report Number: 2134265-2022-07706
• Device Sequence Number: 2517378
• Product Code: DQX
• UDI-Device Identifier: 08714729326212
• UDI-Public: 08714729326212
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/14/2022

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: 11/21/2024
• Device Model Number: 40295
• Device Catalogue Number: 40295
• Device Lot Number: 0028430470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2021
• 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