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

Model Number	H7493919115150
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter facility name: (b)(6).E1.Initial reporter phone: (b)(6).
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed, 3.5mmx20mm target lesion was located in the moderately tortuous and moderately calcified right coronary artery.A 1.50mm x 15mm emerge balloon catheter was advanced for dilation.However, during the procedure, the delivery shaft fractured inside the patient.The procedure was completed with another of same device.There were no patient complications reported and the patient was stable following the procedure.
Additional Manufacturer Narrative
E1.Initial reporter facility name: (b)(6).E1.Initial reporter phone: (b)(6).Device evaluated by mfr: fg emerge otw, us 1.50mm x 15mm was returned for analysis.A visual and tactile inspection identified no issues were noted along the shaft of the device.A visual, tactile and microscopic inspection identified a kink was about 2.5cm from the bumper tip of the device.A microscopic inspection identified there was no sign of damage, stretching or lifting of the stent struts.No signs of movement, stent was set between the proximal and distal markerbands.Balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Bumper tip showed no signs of distal tip damage.
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed, 3.5mmx20mm target lesion was located in the moderately tortuous and moderately calcified right coronary artery.A 1.50mm x 15mm emerge balloon catheter was advanced for dilation.However, during the procedure, the delivery shaft fractured inside the patient.The procedure was completed with another of same device.There were no patient complications reported and the patient was stable following the procedure.

• 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: 21144743
• Report Number: 2124215-2024-83743
• Device Sequence Number: 21106530
• Product Code: LOX
• UDI-Device Identifier: 08714729806790
• UDI-Public: 08714729806790
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K121196
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2025

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 Expiration Date: 03/01/2025
• Device Model Number: H7493919115150
• Device Catalogue Number: H7493919115150
• Device Lot Number: 0031154689
• 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: 12/25/2024
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2023
• 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 Age: 66 YR
• Patient Sex: Male
• Patient Weight: 65 KG