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

Model Number	2842
Medical Device Problem Codes	Difficult to Remove (1528); Unraveled Material (1664)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that removal difficulties occurred, and the patient was sent for bypass surgery.The patient underwent a percutaneous coronary intervention (pci) procedure.The stenosed target lesion was located in the moderately tortuous and moderately calcified mid right coronary artery.A 190cm, straight-tip (5pk) samurai was selected for use.However, when the physician wired the right coronary artery (rca) with the samurai prior to dilating and stenting the blockage, the wire became stuck in a small vessel, and it would not release.The guidewire was entrapped in the artery, and it appeared to be knotted and stretched out.The patient was given nitroglycerin to see if the wire would release but it did not.Since there was also significant disease in the left anterior descending artery (lad), the patient was sent for coronary artery bypass surgery (cabg) for the blockages and guidewire removal.

• Brand Name: SAMURAI
• Common Device Name: CATHETER, GUIDEWIRE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17725917
• Report Number: 2124215-2023-46261
• Device Sequence Number: 7072985
• Product Code: DQX
• UDI-Device Identifier: 08714729881216
• UDI-Public: 08714729881216
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2023

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: 05/31/2026
• Device Model Number: 2842
• Device Catalogue Number: 2842
• Device Lot Number: 0031739866
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CORDIS 6F JL4 GUIDE CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown