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

Model Number	7138
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified diagonal branch.A 1.50mm x 15mm emerge push balloon catheter was advanced for dilatation.However, upon removal of the device, the shaft of the emerge push balloon broke in two and the distal 24cm was left inside the patient.The physician tried to wire aside the fractured shaft and balloon next to it to remove the device but was unsuccessful.The patient was sent to the operating room for surgery and finally, the broken portion of the device was removed.The procedure was completed with no patient complications reported.

• Brand Name: EMERGE PUSH
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12737229
• Report Number: 2134265-2021-13745
• Device Sequence Number: 4127405
• Product Code: LOX
• UDI-Device Identifier: 08714729806011
• UDI-Public: 08714729806011
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K121196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/29/2023
• Device Model Number: 7138
• Device Catalogue Number: 7138
• Device Lot Number: 0027241842
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other