MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JUDO 3; CATHETER, GUIDEWIRE

Model Number	2829
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Vasoconstriction (2126)
Date of Event	10/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1: (b)(6).
Event or Problem Description
It was reported that a vasospasm occurred and required medication.A 190 cm judo 3 guidewire was selected for use.During the procedure, the guidewire advanced to the guiding catheter, but it failed to cross smoothly, and vasospasm occurred.Vasospasm was treated with nitroglycerin.The procedure was completed with a non-boston scientific guidewire device.The patient recovered and was good post procedure.

• Brand Name: JUDO 3
• 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: 18383682
• Report Number: 2124215-2023-70326
• Device Sequence Number: 4210215
• Product Code: DQX
• UDI-Device Identifier: 08714729974956
• UDI-Public: 08714729974956
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K180795
• 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
• Report Date (Section B): 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/11/2026
• Device Model Number: 2829
• Device Catalogue Number: 2829
• Device Lot Number: 0030842078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown