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

Model Number	H7493918915250
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Mid 50¿s female with new onset of severe chest pain and shortness of breath.Procedure: emergent diagnostic heart cath with 3 stents.The emerge balloon was not inflating.It was removed without known harm to patient and there were small pin holes in the balloon.Delay in procedure, a second emerge was used without problems.Manufacturer response for catheters, transluminal coronary angioplasty, percutaneous, emerge¿ (per site reporter) will obtain.

• Brand Name: EMERGE¿
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 15804641
• Report Number: 15804641
• Device Sequence Number: 17546798
• Product Code: LOX
• UDI-Device Identifier: 08714729806219
• UDI-Public: (01)08714729806219(17)250517(10)30152841
• 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): 11/02/2022
• Report Date (Section F): 11/02/2022

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: 30152841
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/16/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/16/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 44 KG
• Date Report Sent to FDA: 11/02/2022