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

Model Number	2842
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 initial reported phone: (b)(6).
Event or Problem Description
It was reported that coating peeling occurred.The 85% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending artery.A 190cm samurai guidewire was selected for use.However, it was noted that the guidewire was peeled.The procedure was completed with another of same device.There were no patient complications reported.Patient was stable.
Event or Problem Description
It was reported that coating peeling occurred.The 85% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending artery.A 190cm samurai guidewire was selected for use.However, it was noted that the guidewire was peeled.The procedure was completed with another of same device.There were no patient complications reported.Patient was stable.
Additional Manufacturer Narrative
E1 initial reported phone:(b)(6).Device evaluated by mfr.: the complaint device was returned for analysis.A j-shaped bend was confirmed about 8mm from the tip of the wire, and a gentle bend was confirmed about 94mm from the tip.In addition, a coil pitch gap of about 1.5mm was confirmed about 15mm from the tip.No peeling or other abnormalities were confirmed in the coating.Other parts were also observed, but no abnormalities were found and no problems were found.There was also media attached to the complaint record.The review of the media concluded that the photo attached to the complaint showed portion of the product pouch with label matching the reported batch number.It appears the wire was inside a hoop within the product pouch but there is no evidence of the reported event in the photo.So, the media is not applicable.

• 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: 19637169
• Report Number: 2124215-2024-38638
• Device Sequence Number: 12536058
• Product Code: DQX
• UDI-Device Identifier: 08714729881216
• UDI-Public: 08714729881216
• 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): 10/01/2024

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 Model Number: 2842
• Device Catalogue Number: 2842
• Device Lot Number: 0032623791
• 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: 06/05/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2023
• 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
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 77 KG