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

Model Number	7132
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon detachment and shaft break occurred.The patient was undergoing percutaneous coronary intervention.The over 80% stenosed complex, bifurcated target lesion was located in the mildly tortuous and moderately calcified diagonal to left anterior descending artery.A 2.00mm x 12mm emerge balloon catheter was used as a trapping balloon within the 6f non-boston scientific guide catheter to pin the guidewire during equipment exchanges.After a microcatheter exchange, it was noticeably identified that moving equipment through the guide was challenging.After panning with the c-arm, a balloon and part of the balloon shaft was stuck in the guide catheter.It was then decided to remove the guidewires and the entire guide catheter system in order to retrieve the balloon.During removal, the entire distal portion of the balloon shaft was fractured within the guide catheter, either during or after using the balloon to trap out the microcatheter in which so much resistance was being felt.The physician upsized to a 7f guide catheter, re-wired the lesions and proceeded to use a 2.00mm x 12mm emerge balloon catheter to complete the procedure successfully.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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19996487
• Report Number: 2124215-2024-48758
• Device Sequence Number: 8363761
• Product Code: LOX
• UDI-Device Identifier: 08714729806080
• UDI-Public: 08714729806080
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 08/15/2024

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 Model Number: 7132
• Device Catalogue Number: 7132
• Device Lot Number: 0033498421
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 08/15/2024
• Date Device Manufactured: 02/26/2024
• 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
• Patient Sex: Unknown