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

Model Number	2828
Medical Device Problem Codes	Difficult to Remove (1528); Unraveled Material (1664); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	01/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that removal difficulties were encountered and distal tip detachment occurred.The 100% stenosed target lesion was located in the mildly tortuous and calcified right coronary artery.A 3, 190 cm judo 3 guide wire was advanced to cross the lesion.However, the wire became stuck in the subintimal plaque and the distal portion unraveled.The physician tried to retrieve the distal tip by ballooning proximally but everything came out and the radiopaque portion broke off.The detached component has been stented across and buried in calcium.The procedure was completed by going retrograde and the sheared off portion of the wire remains in the right coronary artery behind a stent.No complications were reported and patient is stable.
Additional Manufacturer Narrative
Device evaluated by mfr: visual inspection of the returned product revealed that the core wire was severed at 15 mm from the distal tip.The coil was stretched starting from the point at 31 mm from the distal end and severed.Therefore it presumed that about 15 mm of the core and 20mm of the coil part of the core were lost.
Event or Problem Description
It was reported that removal difficulties were encountered and distal tip detachment occurred.The 100% stenosed target lesion was located in the mildly tortuous and calcified right coronary artery.A 3, 190 cm judo 3 guide wire was advanced to cross the lesion.However, the wire became stuck in the subintimal plaque and the distal portion unraveled.The physician tried to retrieve the distal tip by ballooning proximally but everything came out and the radiopaque portion broke off.The detached component has been stented across and buried in calcium.The procedure was completed by going retrograde and the sheared off portion of the wire remains in the right coronary artery behind a stent.No complications were reported and patient is stable.

• 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: 11238795
• Report Number: 2134265-2021-00438
• Device Sequence Number: 3498516
• Product Code: DQX
• UDI-Device Identifier: 08714729974949
• UDI-Public: 08714729974949
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2021

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: 08/26/2022
• Device Model Number: 2828
• Device Catalogue Number: 2828
• Device Lot Number: 0024332614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 01/27/2021
• Supplement Report FDA Received Date: 05/10/2021
• 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: Required Intervention