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

Model Number	7133
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Dyspnea (1816); Fatigue (1849); Ischemic Heart Disease (2493); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B7: other relevant history: added patient history.E4: init rptr also sent rep to fda: changed to no.G2: report source: added user facility.H6: patient code: removed fatigued, ischemic heart disease and dyspnea.
Event or Problem Description
It was reported via user facility or voluntary medwatch/maude report list #3600840000-2024-8012 that shaft break occurred.The patient presented with coronary heart disease, exertional fatigue, and shortness of breath.A 2.50mm x 15mm emerge balloon catheter was advanced for dilatation.However, during catheterization of the device the shaft broke.The device was removed without difficulty, and the procedure was completed with a different device.There were no patient complications or injuries reported.
Event or Problem Description
It was reported that a shaft break occurred.The patient presented with coronary heart disease, exertional fatigue, and shortness of breath.A 2.50mm x 15mm emerge balloon catheter was advanced for dilatation.However, during catheterization of the device the shaft broke.The device was removed without difficulty, and the procedure was completed with a different device.There were no patient complications or injuries 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18727462
• Report Number: 2124215-2024-08079
• Device Sequence Number: 17593706
• Product Code: LOX
• UDI-Device Identifier: 08714729806219
• UDI-Public: 08714729806219
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2024

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 Expiration Date: 07/17/2026
• Device Model Number: 7133
• Device Catalogue Number: 7133
• Device Lot Number: 0032856772
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2024
• Supplement Date Received by Manufacturer: 03/25/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2023
• 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: 84 YR
• Patient Sex: Male
• Patient Weight: 72 KG