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

Model Number	2828
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/30/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tip of the guidewire detached.A percutaneous coronary intervention was being performed on a cto lesion in the circumflex coronary artery.A judo 3 guidewire was able to cross the lesion but the wire prolapsed and became tangled.The body of the guidewire was inside a microcatheter, but the tip of the guidewire was outside of the microcatheter.The guidewire was unable to be pulled into the microcatheter and as they were removing everything from the body, the guidewire tip got stuck on the previously placed stent strut and it snapped off.The guidewire tip was left inside the body.The physician attempted to snare the tip of the guidewire but was not able to do so.The physician placed a second stent inside the previously placed stent so thrombus would not form on the guidewire.There were no patient complications.The patient was fine.

• 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: 9371581
• Report Number: 2134265-2019-13943
• Device Sequence Number: 14076048
• Product Code: DQX
• UDI-Device Identifier: 08714729974949
• UDI-Public: 08714729974949
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K180795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/25/2019

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 Model Number: 2828
• Device Catalogue Number: 2828
• Device Lot Number: 0023865872
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 11/25/2019
• 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: Required Intervention