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

Model Number	40295
Medical Device Problem Codes	Difficult to Remove (1528); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulty occurred.The patient presented with peripheral arterial disease and underwent angiogram.The chronically totally occluded target lesion was located in the non-tortuous and severely calcified distal anterior tibial artery.A 018/260cm platinum plus guidewire was advanced.Upon crossing the lesion, the guidewire prolapsed into a knot and could not be removed through the 018 sterling balloon catheter or the 035 rubicon guide catheter.The guidewire was removed intact with the guide catheter.However, during withdrawal, the guidewire tip completely unraveled.The procedure was completed with a 014 savion guidewire.No patient complications were reported.
Event or Problem Description
It was reported that removal difficulty occurred.The patient presented with peripheral arterial disease and underwent angiogram.The chronically totally occluded target lesion was located in the non-tortuous and severely calcified distal anterior tibial artery.A 018/260cm platinum plus guidewire was advanced.Upon crossing the lesion, the guidewire prolapsed into a knot and could not be removed through the 018 sterling balloon catheter or the 035 rubicon guide catheter.The guidewire was removed intact with the guide catheter.However, during withdrawal, the guidewire tip completely unraveled.The procedure was completed with a 014 savion guidewire.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the guidewire was returned for this complaint, and it was observed that the coil wire was unraveled, and the core wire was detached at 2.5 cm from the distal tip to the transition point.Under microscope it was observed that the core wire was detached at the transition point.The outer diameter of the distal, middle and proximal sections of the device are within specifications.

• 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: 15974516
• Report Number: 2124215-2022-50615
• Device Sequence Number: 17606988
• Product Code: DQX
• UDI-Device Identifier: 08714729326212
• UDI-Public: 08714729326212
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2023

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: 05/22/2025
• Device Model Number: 40295
• Device Catalogue Number: 40295
• Device Lot Number: 0029452427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/26/2022
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2022
• 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 Age: 87 YR
• Patient Sex: Female