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

Model Number	2842
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that a catheter issue occurred.The patient presented for a bifurcation percutaneous coronary intervention (pci) procedure.The target lesion was located in a calcified left anterior descending coronary artery (lad).A non-boston scientific (non-bsc) guidewire was placed and an opticross hd vascular imaging catheter was advanced over a samurai guidewire for ultrasound examination of the target lesion.During pullback, the image disappeared.The pullback stopped after approximately 4cm.The physician attempted to bring the catheter back into starting position, but it did not work, and the opticross catheter was stuck with the guidewire.It was noted that the catheter looked like a corkscrew.Everything was removed together, and the procedure was successfully completed with other devices.There was no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the samurai guidewire was returned for analysis.A wavy bend was confirmed about 28mm from the tip of the wire, a kink with an inner angle of about 130 degree was confirmed about 34mm from the tip, and an arc-0shaped bend was confirmed about 278mm from the tip.In addition, peeling of the ptfe coating was confirmed in seven places in the range of about 223mm to 288mm from the tip.Other parts were also observed, but no abnormalities were found, and no problems were found during returned product analysis.Product analysis confirmed the reported event, based off the damage on the returned device.E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that a catheter issue occurred.The patient presented for a bifurcation percutaneous coronary intervention (pci) procedure.The target lesion was located in a calcified left anterior descending coronary artery (lad).A non-boston scientific (non-bsc) guidewire was placed and an opticross hd vascular imaging catheter was advanced over a samurai guidewire for ultrasound examination of the target lesion.During pullback, the image disappeared.The pullback stopped after approximately 4cm.The physician attempted to bring the catheter back into starting position, but it did not work, and the opticross catheter was stuck with the guidewire.It was noted that the catheter looked like a corkscrew.Everything was removed together, and the procedure was successfully completed with other devices.There was no patient complications reported.

• 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: 20158880
• Report Number: 2124215-2024-55023
• Device Sequence Number: 12854262
• Product Code: DQX
• UDI-Device Identifier: 08714729881216
• UDI-Public: 08714729881216
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2025

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: 2842
• Device Catalogue Number: 2842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown