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

Model Number	7132
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.During preparation of a 2.50mm x 12mm emerge balloon catheter, it was noticed that the hypo tube portion of the balloon was not straight and looked almost line an "s".It was also noticed that there was a fracture on the shaft.The procedure was completed with no patient complications reported.
Additional Manufacturer Narrative
B3 date of event: used the first day of the month of bsc aware date since event date was not provided.
Additional Manufacturer Narrative
B3 date of event: used the first day of the month of bsc aware date since event date was not provided.Device evaluated by mfr.: the returned product consisted of an emerge mr balloon catheter.The device was visually and microscopically examined.There were no fluids in the device, and the balloon was tightly folded.There was separation of the guidewire at the proximal end of the bicomponent weld.The guidewire lumen was stretched for a length of 1mm, 2mm distal from the separation.There were numerous bends to the distal portion of the shaft from rapid port exchange to the tip of the device.Also, media depicted a separation from the guidewire lumen within the inflation lumen at the bicomponent weld area, with numerous bends visible to the shaft which confirms the reported events and aligns with the analysis.Product analysis confirmed the reported events, as there was guidewire lumen separation from the device and numerous bends to the shaft of the device.
Event or Problem Description
It was reported that shaft break occurred.During preparation of a 2.50mm x 12mm emerge balloon catheter, it was noticed that the hypo tube portion of the balloon was not straight and looked almost line an "s".It was also noticed that there was a fracture on the shaft.The procedure was completed 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: 17375505
• Report Number: 2124215-2023-36322
• Device Sequence Number: 3715582
• Product Code: LOX
• UDI-Device Identifier: 08714729806103
• UDI-Public: 08714729806103
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2023

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: 11/12/2025
• Device Model Number: 7132
• Device Catalogue Number: 7132
• Device Lot Number: 0031221986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2023
• Supplement Date Received by Manufacturer: 09/12/2023
• Initial Report FDA Received Date: 07/22/2023
• Supplement Report FDA Received Date: 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2023
• 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