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

Model Number	2842
Medical Device Problem Codes	Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was difficulty removing the device.The target lesion was located in the mildly tortuous and mildly calcified left anterior descending artery (lad).A 190cm samurai guidewire was selected for use in a percutaneous coronary intervention (pci).The non-boston scientific balloon inflated to 26 atm and inflated it about 6 to 7 times.During withdrawal, the non-boston scientific balloon was no longer possible to retrieve and it became stuck on the samurai guidewire.The guidewire position was lost.The devices were removed from the patient's body together.The procedure was completed with a this device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the product was returned stuck inside the concomitant-use balloon catheter.After disinfection, the wire insertion port of the balloon catheter was cut by about 1 cm and the product was able to be removed by pulling on the proximal end.At that time, a thrombus-like material was confirmed inside the balloon catheter together with the product.It was confirmed that the product was kinked at 20 mm and 125 mm from the tip and the core shaft was deformed into a wavy shape.
Event or Problem Description
It was reported that there was difficulty removing the device.The target lesion was located in the mildly tortuous and mildly calcified left anterior descending artery (lad).A 190cm samurai guidewire was selected for use in a percutaneous coronary intervention (pci).The non-boston scientific balloon inflated to 26 atm and inflated it about 6 to 7 times.During withdrawal, the non-boston scientific balloon was no longer possible to retrieve and it became stuck on the samurai guidewire.The guidewire position was lost.The devices were removed from the patient's body together.The procedure was completed with a this device.There were no patient complications nor injuries reported.

• Brand Name: SAMURAI
• Common Device Name: CATHETER, GUIDEWIRE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12713000
• Report Number: 2134265-2021-13575
• Device Sequence Number: 4703826
• Product Code: DQX
• UDI-Device Identifier: 08714729881216
• UDI-Public: 08714729881216
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2022

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: 05/21/2024
• Device Model Number: 2842
• Device Catalogue Number: 2842
• Device Lot Number: 0027361115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2021
• 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: 3.0 X 12MM NC EUPHORA - MEDTRONIC; 3.0 X 12MM NC EUPHORA - MEDTRONIC; 3.0 X 12MM NC EUPHORA - MEDTRONIC.
• Patient Sex: Unknown