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

Model Number	H7493926712450
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Patient with history of hypertension and congestive heart failure was admitted for a diagnostic catheterization with percutaneous transluminal coronary angiogram.The left main wire fractured, from the nc emerge® ptca dilatation catheter, broke in half during the procedure.The device was removed without difficulty and no known harm to patient.

• Brand Name: NC 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: 12187757
• Report Number: 12187757
• Device Sequence Number: 4225924
• Product Code: LOX
• UDI-Device Identifier: 08714729846444
• UDI-Public: (01)08714729846444(17)230503(10)27241865
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/09/2021
• Report Date (Section F): 07/09/2021

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: H7493926712450
• Device Catalogue Number: H7493926712450
• Device Lot Number: 27241865
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/19/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/19/2021
• Patient Sequence Number: 1
• Patient Weight: 83
• Date Report Sent to FDA: 07/09/2021