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

Model Number	2842
Medical Device Problem Codes	Contamination (1120); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6) hospital.E1: initial reporter phone number: (b)(6).
Event or Problem Description
It was reported that a foreign object was present which leads to a device contamination.During preparation and prior to opening the package of a 190 cm samurai guidewire, a foreign object was observed inside the packaging and compromised the sterility of the device.The procedure was completed with a different device.The patient condition following the procedure was stable.
Event or Problem Description
It was reported that a foreign object was present which leads to a device contamination.During preparation and prior to opening the package of a 190 cm samurai guidewire, a foreign object was observed inside the packaging and compromised the sterility of the device.The procedure was completed with a different device.The patient condition following the procedure was stable.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).E1: initial reporter phone number: (b)(6).Device evaluated by mfr.: the samurai device was returned in a sealed product pouch.Visual and microscopic inspection revealed that the product pouch had a complete seal and there was red foreign material present inside the packaging approximately 1.5cm in length.The foreign material was in the bottom left corner of the pouch under the label near the bottom seal.Media was also provided and examined.The photo showed the sealed samurai device with foreign material visible in the bottom left corner of the pouch.The media matches the returned device.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 22745604
• Report Number: 2124215-2025-51389
• Device Sequence Number: 11893708
• Product Code: DQX
• UDI-Device Identifier: 08714729881216
• UDI-Public: (01)08714729881216(17)270408(10)33783841
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2025

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
• Device Lot Number: 0033783841
• 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: 07/17/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2024
• 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 Age: 65 YR
• Patient Sex: Male
• Patient Weight: 78 KG