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

Model Number	39935
Medical Device Problem Codes	Difficult to Remove (1528); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an entrapment of device occurred.The almost occluded and stenosed target lesion was located in an artery in the right leg.A 018/180 platinum plus-3 guidewire was advance for use.The physician tried to recanalize the calcified lesion with back and forth movement, however the tip of the wire got stuck in the lesion.The physician tried to pull the guidewire back, but it stuck very tightly within the lesion.During the removal attempt the guidewire moved back and the wire started to fray as the tip remained stuck in the lesion.The device was completely taken out from the patient.The procedure is completed with a different device.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.Unit returned with its original box.The unit returned has tip damage, as part of overall visual revision.The guidewire returned with the distal section unraveled and with corewire bent at distal end.No evidence of corewire fractured.The outer diameter dimensions were found within specification.
Event or Problem Description
It was reported that an entrapment of device occurred.The almost occluded and stenosed target lesion was located in an artery in the right leg.A 018/180 platinum plus-3 guidewire was advance for use.The physician tried to recanalize the calcified lesion with back and forth movement, however the tip of the wire got stuck in the lesion.The physician tried to pull the guidewire back, but it stuck very tightly within the lesion.During the removal attempt the guidewire moved back and the wire started to fray as the tip remained stuck in the lesion.The device was completely taken out from the patient.The procedure is completed with a different device.There were no patient complications reported and the patient status 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
• MDR Report Key: 8531480
• Report Number: 2134265-2019-04131
• Device Sequence Number: 1954969
• Product Code: DQX
• UDI-Device Identifier: 08714729114567
• UDI-Public: 08714729114567
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K935997
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2019

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: 08/15/2021
• Device Model Number: 39935
• Device Catalogue Number: 39935
• Device Lot Number: 0022524872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2019
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 04/19/2019
• Supplement Report FDA Received Date: 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1