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

Model Number	H749393021900
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).E1: initial reporter facility: (b)(6).Device evaluated by mfr: the samurai guidewire was returned for analysis.It was confirmed that the hemispherical part of the distal wire tip (about 0.3mm range from the tip of the wire) was missing.The missing tip hemispherical part was not returned.A small bend at about 4mm from the distal tip of the wire and a gentle bend at about 27mm from the distal tip were also observed.No other abnormalities were observed.
Event or Problem Description
Reportable based on device analysis completed on 03-nov-2023.It was reported that crossing difficulties occurred.The target lesion is located in the left circumflex artery.A 190cm, straight-tip samurai guidewire failed to cross the lesion.The procedure was completed with another of the same device.No patient complications were reported.However, returned device analysis revealed that distal tip detachment occurred.
Additional Manufacturer Narrative
This report is being filed to correct the model number and unique identifier (udi) # in response to an fda request.E1: initial reporter phone: (b)(6).E1: initial reporter facility: (b)(6) hospital.Device evaluated by mfr: the samurai guidewire was returned for analysis.It was confirmed that the hemispherical part of the distal wire tip (about 0.3mm range from the tip of the wire) was missing.The missing tip hemispherical part was not returned.A small bend at about 4mm from the distal tip of the wire and a gentle bend at about 27mm from the distal tip were also observed.No other abnormalities were observed.
Event or Problem Description
Reportable based on device analysis completed on 03-nov-2023.It was reported that crossing difficulties occurred.The target lesion is located in the left circumflex artery.A 190cm, straight-tip samurai guidewire failed to cross the lesion.The procedure was completed with another of the same device.No patient complications were reported.However, returned device analysis revealed that distal tip detachment occurred.

• 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: 18231380
• Report Number: 2124215-2023-64865
• Device Sequence Number: 15003355
• Product Code: DQX
• UDI-Device Identifier: 08714729881216
• UDI-Public: (01)08714729881216(17)250421(10)29272755
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2024

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 Expiration Date: 04/21/2025
• Device Model Number: H749393021900
• Device Catalogue Number: 2842
• Device Lot Number: 0029272755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2023
• Supplement Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2022
• 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: 54 YR
• Patient Sex: Male
• Patient Weight: 78 KG