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

Model Number	H7493918912250
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the shaft break occurred requiring additional intervention.The target lesion was located in coronary artery.A 2.50mm x 12mm emerge balloon catheter was advanced for dilatation.However, during the procedure, the middle shaft was fractured.The detached portion was completely removed with a snare.The procedure was completed using an alternative device and no patient complications were reported.
Additional Manufacturer Narrative
Premarket / 510(k) #: k163174.
Additional Manufacturer Narrative
Premarket / 510(k) #: k163174 device evaluated by mfr.: fg emerge mr, us 2.50mm x 12mm, catheter was returned for analysis.Visual, tactile and microscopic analysis was performed on the device.A visual and tactile examination of the hypotube found multiple kinks along the shaft and a break at 74cm distal to the distal end of the strain relief.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.A microscopic examination of the proximal and distal markerbands identified no damage.A microscopic examination of the tip showed no signs of tip damage.
Event or Problem Description
It was reported that the shaft break occurred requiring additional intervention.The target lesion was located in coronary artery.A 2.50mm x 12mm emerge balloon catheter was advanced for dilatation.However, during the procedure, the middle shaft was fractured.The detached portion was completely removed with a snare.The procedure was completed using an alternative device and no patient complications were reported.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 22071617
• Report Number: 2124215-2025-28615
• Device Sequence Number: 15603457
• Product Code: LOX
• UDI-Device Identifier: 08714729806103
• UDI-Public: (01)08714729806103(17)270813(10)35465250
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 07/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H7493918912250
• Device Catalogue Number: H7493918912250
• Device Lot Number: 0035465250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown