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

Model Number	39935
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guidewire tip broke and remained inside the patient's body.The target lesion was located in the tibial vessel.A 018/260 platinum plus guidewire was selected for use.During the procedure, it was noted that the tip broke off in the patient and it was unable to be removed from the patient's anatomy.No further patient complications were reported and the procedure was not completed due to unknown reasons.
Event or Problem Description
It was reported that the guidewire tip broke and remained inside the patient's body.The target lesion was located in the tibial vessel.A 018/260 platinum plus guidewire was selected for use.During the procedure, it was noted that the tip broke off in the patient and it was unable to be removed from the patient's anatomy.No further patient complications were reported and the procedure was not completed due to unknown reasons.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.Visual inspection revealed that the device returned has a kink at 286.5cm from the distal end.No evidence of coil broken was observed, since the total length of the tip is 300cm approximately.Dimensional inspection revealed that the outer diameter distal end, mid section and proximal section of the device were within specification.

• 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: 8151425
• Report Number: 2134265-2018-63827
• Device Sequence Number: 267737
• Product Code: DQX
• UDI-Device Identifier: 08714729114574
• UDI-Public: 08714729114574
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K935997
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/29/2021
• Device Model Number: 39935
• Device Catalogue Number: 39935
• Device Lot Number: 0022589431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Initial Date Received by Manufacturer: 11/16/2018
• Supplement Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 12/11/2018
• Supplement Report FDA Received Date: 02/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER: RUBICON; GUIDE CATHETER: RUBICON; GUIDE CATHETER: RUBICON
• Outcome Attributed to Adverse Event: Other