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

Model Number	7133
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon burst.An fg emerge mr, us 2.50 x 15mm was selected for treatment of the target lesion.During the procedure, the balloon had burst.The device was completely removed from the patient, and another similar device was used to successfully complete the procedure.There were no patient complications.
Event or Problem Description
It was reported that a balloon burst.An fg emerge mr, us 2.50 x 15mm was selected for treatment of the target lesion.During the procedure, the balloon had burst.The device was completely removed from the patient, and another similar device was used to successfully complete the procedure.There were no patient complications.It was later reported that the balloon burst after it was inflated one time up to 12 atm for 8 seconds.The target lesion was 20%-40% stenosed, severely calcified, and moderately tortuous.

• Brand Name: EMERGE
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19772900
• Report Number: 2124215-2024-44369
• Device Sequence Number: 8574652
• Product Code: LOX
• UDI-Device Identifier: 08714729806219
• UDI-Public: 08714729806219
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K113220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024

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: 7133
• Device Catalogue Number: 7133
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 08/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown