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

Model Number	39895
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was approximated as event date was not reported.
Event or Problem Description
It was reported that guidewire fracture occured.A 018/180 platinum plus guidewire was advanced to treat the lesion through a guide catheter.However, near the end of the procedure, it was noted that the wire was separating, but had not completely detached upon imaging.The procedure was completed with this device.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that guidewire fracture occured.A 018/180 platinum plus guidewire was advanced to treat the lesion through a guide catheter.However, near the end of the procedure, it was noted that the wire was separating, but had not completely detached upon imaging.The procedure was completed with this device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Date of event was approximated as event date was not reported.Device evaluated by mfr: the device was returned with its original box labeled batch 22492297.The unit returned has a bent and unraveled tip.There was no evidence of a corewire fracture.The outer diameter dimensions were found 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: 8391159
• Report Number: 2134265-2019-02050
• Device Sequence Number: 1471430
• Product Code: DQX
• UDI-Device Identifier: 08714729035954
• UDI-Public: 08714729035954
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K935997
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2019

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: 08/08/2021
• Device Model Number: 39895
• Device Catalogue Number: 39895
• Device Lot Number: 0022492297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Initial Date Received by Manufacturer: 02/12/2019
• Supplement Date Received by Manufacturer: 03/26/2019
• Initial Report FDA Received Date: 03/05/2019
• Supplement Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1