MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SAMURAI; CATHETER, GUIDEWIRE

Model Number	2846
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.The returned product showed the core was severed and the coil was stretched.The core wire was severed at about 2mm from the distal tip.The coil was greatly stretched starting at 38mm from the distal tip towards the distal end.In addition, it was confirmed that the 2mm core fragment was enclosed by the stretched distal coil tip, and no part of the core coil was missing.
Event or Problem Description
Reportable based on device analysis completed on 21-aug-2019.It was reported that guide wire damage occurred.A 190cm samurai guide wire was selected for use; however, it was noted that the guide wire was damaged during introduction.The procedure was completed with a different device.No patient complications were reported.However, returned device analysis revealed wire core detachment.

• Brand Name: SAMURAI
• Common Device Name: CATHETER, GUIDEWIRE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8962179
• Report Number: 2134265-2019-10377
• Device Sequence Number: 3146943
• Product Code: DQX
• UDI-Device Identifier: 08714729887836
• UDI-Public: 08714729887836
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K151840
• 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
• Report Date (Section B): 09/04/2019

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: 05/23/2021
• Device Model Number: 2846
• Device Catalogue Number: 2846
• Device Lot Number: 0022135068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 09/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1