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

Model Number	7132
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the mildly tortuous coronary artery.A 2.00mm x 12mm emerge balloon catheter was advanced for dilation.However, during inflation at less than 12 atmospheres and before reaching nominal pressure, the balloon ruptured.The procedure was completed with an alternative device.No patient complications were reported.
Additional Manufacturer Narrative
B5.Describe event or problem updated.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the mildly tortuous coronary artery.A 2.00mm x 12mm emerge balloon catheter was advanced for dilation.However, during inflation at less than 12 atmospheres and before reaching nominal pressure, the balloon ruptured.The procedure was completed with an alternative device.No patient complications were reported.It was further reported that the target lesion was located in the fatty plaque with possible calcium in the left anterior descending artery.Additionally, the balloon was inflated once.

• 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; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19168938
• Report Number: 2124215-2024-24169
• Device Sequence Number: 20678129
• Product Code: LOX
• UDI-Device Identifier: 08714729806080
• UDI-Public: 08714729806080
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2024

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: 7132
• Device Catalogue Number: 7132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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