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

Model Number	2828
Medical Device Problem Codes	Failure to Advance (2524); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event estimated based on aware date.
Event or Problem Description
It was reported via medwatch (b)(4) that a guidewire break occurred and a device fragment remained in the patient.The patient presented with a calcified 100% ostial lesion in the left subclavian and tubular 50% ostial lesion in the right subclavian.The patient underwent a peripheral angiography.The judo guidewire was introduced but was unable to cross the left subclavian occlusion both retrograde and antegrade.Part of the device broke off and ended up in a subintimal plane with no risk of embolization.

• Brand Name: JUDO 3
• Common Device Name: CATHETER, GUIDEWIRE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11809831
• Report Number: 2134265-2021-06164
• Device Sequence Number: 11622116
• Product Code: DQX
• UDI-Device Identifier: 08714729974963
• UDI-Public: 08714729974963
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2021

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: 09/02/2022
• Device Model Number: 2828
• Device Catalogue Number: 2828
• Device Lot Number: 0024364535
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR