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

Model Number	40375
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/20/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment occurred.A platinum plus was inserted to the target lesion.However during procedure, it was noted that the distal portion of wire separated inside the patient's body.Patient injury occurred and the physician removed the device after which the patient was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: investigation completed on the returned device revealed tip damage in the form of stretching/unraveling and the tip was detached.Dimensional inspection revealed the outer diameter of the distal section, middle section, and proximal section of the device were all within specifications.Inspection revealed no other damage or irregularities.
Event or Problem Description
It was reported that tip detachment occurred.A platinum plus was inserted to the target lesion.However during procedure, it was noted that the distal portion of wire separated inside the patient's body.Patient injury occurred and the physician removed the device after which the patient was fine.

• 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: 8240205
• Report Number: 2134265-2018-65039
• Device Sequence Number: 2189655
• Product Code: DQX
• UDI-Device Identifier: 08714729486886
• UDI-Public: 08714729486886
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K945379
• 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): 03/01/2019

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: 10/03/2021
• Device Model Number: 40375
• Device Catalogue Number: 40375
• Device Lot Number: 0022748580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Initial Date Received by Manufacturer: 12/27/2018
• Supplement Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 03/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention