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

Model Number	2834
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/27/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire fracture occurred.A 190cm, straight-tip samurai rc guidewire was selected for use.However, during the procedure, the device got broken.The procedure was completed with another of same device.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that guidewire fracture occurred.A 190cm, straight-tip samurai rc guidewire was selected for use.However, during the procedure, the device got broken.The procedure was completed with another of same device.There were no patient complications nor injuries reported.It was further reported that the part of the device that was damaged is the distal tip, where the inner coil technology (ict) is located.
Additional Manufacturer Narrative
Device evaluated by mfr.: a kink and pitch elongation of the coil at about 5 mm from the distal tip were observed through examination of the returned product.Other than these observations, no other abnormalities were seen.
Event or Problem Description
It was reported that guidewire fracture occurred.A 190cm, straight-tip samurai rc guidewire was selected for use.However, during the procedure, the device got broken.The procedure was completed with another of same device.There were no patient complications nor injuries reported.It was further reported that the part of the device that was damaged is the distal tip, where the inner coil technology (ict) is located.

• Brand Name: SAMURAI RC
• Common Device Name: CATHETER, GUIDEWIRE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9239678
• Report Number: 2134265-2019-12920
• Device Sequence Number: 1611540
• Product Code: DQX
• UDI-Device Identifier: 08714729887737
• UDI-Public: 08714729887737
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/16/2020

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 Model Number: 2834
• Device Catalogue Number: 2834
• Device Lot Number: 0022013002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 10/24/2019; 06/11/2020
• Initial Report FDA Received Date: 10/25/2019
• Supplement Report FDA Received Date: 11/11/2019; 06/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR