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

Model Number	7132
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 2.00mm x 12mm emerge balloon catheter was advanced for dilation.However, during the procedure, the balloon broke.The device was removed intact from the patient.The procedure was completed successfully with no patient complications reported.
Additional Manufacturer Narrative
Date of event- used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that shaft break occurred.A 2.00mm x 12mm emerge balloon catheter was advanced for dilation.However, during the procedure, the balloon broke.The device was removed intact from the patient.The procedure was completed successfully with no patient complications reported.
Additional Manufacturer Narrative
Updated b3: date of event from (b)(6) 2024 to (b)(6) 2024 device evaluated by mfr: returned product consisted of an emerge mr balloon catheter.A visual inspection revealed that at 41.6cm from the strain relief, the hypotube was separated.There were numerous hypotube kinks to the device.A microscopic inspection revealed no damage or irregularity.There were no fluids present to the device, and the balloon was tightly folded.Product analysis confirmed the reported break as there was separation to the device.
Additional Manufacturer Narrative
Updated b3: date of event from (b)(6) 2024 to (b)(6) 2024.
Event or Problem Description
It was reported that shaft break occurred.A 2.00mm x 12mm emerge balloon catheter was advanced for dilation.However, during the procedure, the balloon broke.The device was removed intact from the patient.The procedure was completed successfully with no patient complications 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: 18585966
• Report Number: 2124215-2024-03707
• Device Sequence Number: 15216287
• Product Code: LOX
• UDI-Device Identifier: 08714729806080
• UDI-Public: 08714729806080
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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,Followup
• Report Date (Section B): 03/20/2024

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: 03/09/2026
• Device Model Number: 7132
• Device Catalogue Number: 7132
• Device Lot Number: 0031972237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/17/2024
• Supplement Date Received by Manufacturer: 01/29/2024; 03/18/2024
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 02/14/2024; 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2023
• 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 Sex: Unknown