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

Model Number	7134
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event: used the first date of the month of the aware date.As the event date provided was on later date, than the aware date.E1.Initial reporter phone: (b)(6).
Event or Problem Description
It was reported, that balloon rupture occurred.The patient presented with chest pain.The 28x3.0mm, 90% stenosed, de novo target lesion contained a <45 degrees bend.And was located in the mildly tortuous, and severely calcified left circumflex artery.A 2.00mm x 20mm emerge balloon catheter was advanced for dilation.However, during the inflation at nominal pressure, the balloon ruptured.The device was removed.And the procedure was completed with another of the same device.No patient complications were reported.And the patient status was stable.
Additional Manufacturer Narrative
Updated: b3.Date of event.E1.Initial reporter phone: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented with chest pain.The 28x3.0mm, 90% stenosed, de novo target lesion contained a <=45 degrees bend and was located in the mildly tortuous and severely calcified left circumflex artery.A 2.00mm x 20mm emerge balloon catheter was advanced for dilation.However, during the first inflation in the at nominal pressure, the balloon ruptured.The device was removed and the procedure was completed with another of the same device.No patient complications were reported, and the patient status was stable.It was further reported that the balloon ruptured during initial inflation at 10 atmospheres for 5 seconds.

• 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: 17213074
• Report Number: 2124215-2023-32928
• Device Sequence Number: 6433667
• Product Code: LOX
• UDI-Device Identifier: 08714729806301
• UDI-Public: 08714729806301
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2023

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: 02/10/2024
• Device Model Number: 7134
• Device Catalogue Number: 7134
• Device Lot Number: 0027493709
• 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: 06/14/2023
• Supplement Date Received by Manufacturer: 07/02/2023
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2021
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 50 KG