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

Model Number	2834
Medical Device Problem Codes	Difficult to Remove (1528); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
If reported via user facility or voluntary medwatch # (b)(4) that removal difficulty occurred.The target lesion was located in the coronary artery.During a percutaneous coronary intervention involving a 190cm, straight-tip samurai rc guidewire, resistance was encountered during an attempt to remove the device.The physician had to thread another sheath over the top of the guidewire to remove it safety from the patient.Upon inspection, the tip of the device was found frayed and possibly unraveled.The procedure was completed with a different device.There were no patient complications nor injuries reported.

• 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: 11940790
• Report Number: 2134265-2021-07113
• Device Sequence Number: 4066363
• Product Code: DQX
• UDI-Device Identifier: 08714729887737
• UDI-Public: 08714729887737
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K151840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/04/2021

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: 07/31/2023
• Device Model Number: 2834
• Device Catalogue Number: 2834
• Device Lot Number: 0025797125
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 06/04/2021
• 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
• Patient Age: 68 YR
• Patient Weight: 113