MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CHOICE EXTRA SUPPORT GUIDEWIRE; BALLOON ANGIOPLASTY GUIDEWIRE

Model Number	H7491211901J1
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During pci of the circumflex artery, while physician was attempting to place pci wire across the stenotic lesion the proximal flexible portion of the wire tip broke off and remained in the circumflex artery.Multiple attempts were made to retrieve the broken wire from the vessel but all failed.

• Brand Name: CHOICE EXTRA SUPPORT GUIDEWIRE
• Common Device Name: BALLOON ANGIOPLASTY GUIDEWIRE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8836435
• Report Number: 8836435
• Device Sequence Number: 11451304
• Product Code: DQX
• UDI-Device Identifier: 08714729193685
• UDI-Public: 08714729193685
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/16/2019
• Report Date (Section F): 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H7491211901J1
• Device Catalogue Number: H7491211901J1
• Device Lot Number: 22721978
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/15/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Date Report Sent to FDA: 07/16/2019