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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the shaft break occurred.A 2.00mm x 15mm emerge balloon catheter was selected for use.However, during preparation, the catheter broke before going into the body.The physician pulled a new device, and the procedure was completed.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Date of event- used the first date of the month of the aware date as no event date was provided.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of the emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.The balloon was tightly folded.There were numerous kinks throughout the hypotube of the device.There was a complete hypotube separation 82cm distal of the strain relief.The hypotube fracture surfaces were ovaled, which suggests the device was kinked prior to separation.Product analysis confirmed the reported event, as the hypotube was separated.B3.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 the shaft break occurred.A 2.00mm x 15mm emerge balloon catheter was selected for use.However, during preparation, the catheter broke before going into the body.The physician pulled a new device, and the procedure was completed.There were no patient complications nor injuries reported.

• Brand Name: EMERGE
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15803971
• Report Number: 2124215-2022-47383
• Device Sequence Number: 5401934
• Product Code: LOX
• UDI-Device Identifier: 08714729806196
• UDI-Public: 08714729806196
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2022

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: 01/05/2025
• Device Model Number: 7133
• Device Catalogue Number: 7133
• Device Lot Number: 0029376167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/09/2022
• Supplement Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 11/16/2022
• Supplement Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2022
• 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