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

Model Number	2828
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Vasoconstriction (2126); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).E1: initial reporter address 1: (b)(6).E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that guidewire fracture occurred.The over 90% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending artery (lad).A 190 cm, straight tip, judo 3 guidewire was advanced for treatment.However, when the device was withdrawn from the patient's body, the spring coil section of the guidewire fractured around 180cm.The device was removed using guidezilla (gz), lower balloon with low pressure dilation and retraction removal.The procedure was completed with a non-boston scientific (bsc) device.There was no patient complication reported and the patient was in good condition.
Additional Manufacturer Narrative
B5 - describe event or problem: updated to include new information obtained.E1: initial reporter facility name: (b)(6).E1: initial reporter address 1: (b)(6).E1: initial reporter phone: (b)(6).H6: patient and impact codes: updated.
Event or Problem Description
It was reported that guidewire fracture occurred.The over 90% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending artery (lad).A 190 cm, straight tip, judo 3 guidewire was advanced for treatment.However, when the device was withdrawn from the patient's body, the spring coil section of the guidewire fractured around 180cm.The device was removed using guidezilla (gz), lower balloon with low pressure dilation and retraction removal.The procedure was completed with a non-boston scientific (bsc) device.There was no patient complication reported and the patient was in good condition.It was further reported that there are no obvious complications, and the immediate manifestation was vasospasm.

• 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: 18226917
• Report Number: 2124215-2023-66437
• Device Sequence Number: 5557146
• Product Code: DQX
• UDI-Device Identifier: 08714729974949
• UDI-Public: 08714729974949
• 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,Followup
• Report Date (Section B): 12/01/2023

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: 2828
• Device Catalogue Number: 2828
• Device Lot Number: 0030842078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/03/2023
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 12/01/2023
• 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