MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	H7493918915250
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Coronary balloon catheter - shaft portion of catheter snapped into 2 pieces.Both pieces were still on coronary wire and moved into guide catheter and removed from the body.Had to pull whole setup out except sheath.

• Brand Name: EMERGE
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 17956538
• Report Number: 17956538
• Device Sequence Number: 15205550
• Product Code: LOX
• UDI-Device Identifier: 08714729806219
• UDI-Public: (01)08714729806219
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/04/2023
• Report Date (Section F): 10/04/2023

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: H7493918915250
• Device Lot Number: 31740147
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/18/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/18/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 118 KG
• Patient Race: White
• Date Report Sent to FDA: 10/04/2023