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

Model Number	40375
Medical Device Problem Codes	Unraveled Material (1664); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a tip break occurred.A platinum plus guidewire was selected for use in a percutaneous transluminal angioplasty (pta) procedure to treat critical limb ischemia.During the procedure, approximately 1 cm of the tip of the guidewire split or broke off.The fine spiral that was wrapped around the tip unwound.The procedure was completed using the original device.There were no patient complications.
Additional Manufacturer Narrative
Device evaluated by mfr: the product was returned to boston scientific for analysis, and it was observed that the core wire was found separated from the bald weld.The guidewire was unraveled, stretched and bent at spring tip section.
Event or Problem Description
It was reported that a tip break occurred.A platinum plus guidewire was selected for use in a percutaneous transluminal angioplasty (pta) procedure to treat critical limb ischemia.During the procedure, approximately 1 cm of the tip of the guidewire split or broke off.The fine spiral that was wrapped around the tip unwound.The procedure was completed using the original device.There were no patient complications.

• Brand Name: PLATINUM PLUS
• 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; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20750325
• Report Number: 2124215-2024-73120
• Device Sequence Number: 17246525
• Product Code: DQX
• UDI-Device Identifier: 08714729486886
• UDI-Public: 08714729486886
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2025

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: 40375
• Device Catalogue Number: 40375
• Device Lot Number: 0033259316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Supplement Date Received by Manufacturer: 02/15/2025
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown