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

Model Number	40375
Medical Device Problem Codes	Stretched (1601); Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date the incident occurred was estimated as (b)(6) 2019 which is the first day of the month of the notification date.Device evaluated by mfr.: the device was returned for analysis.Analysis of returned device revealed tip damage and distal section stretch (coil unraveled).The tip was observed detached off the corewire.There was no evidence of corewire fracture since the length of the corewire is 300.0 cm approximately.The outer diameter dimensions were found within specification.
Event or Problem Description
Reportable based on device analysis completed on 17-jul-2019.It was reported that tip damage occurred.A 014/300/sst platinum plus guidewire was selected for use.However, during unpacking, it was noticed that the tip was damaged, bent, stretched, and elongated when removed from the sheath.Another of the same device was used to complete the procedure.No patient complications were reported.However, returned device analysis revealed the distal tip was detached.

• 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: 8826708
• Report Number: 2134265-2019-08691
• Device Sequence Number: 19476899
• Product Code: DQX
• UDI-Device Identifier: 08714729486886
• UDI-Public: 08714729486886
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K945379
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/25/2019

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: 10/29/2021
• Device Model Number: 40375
• Device Catalogue Number: 40375
• Device Lot Number: 0022864865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 07/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1