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

Model Number	7214
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break occurred.A 4.00mm x 20mm nc emerge balloon catheter was advanced for dilation.However, during procedure, it was noted that the balloon broke off inside the patient.The device was snared and removed intact from the patient.Another balloon was used to complete the procedure.There were no patient complications reported.
Additional Manufacturer Narrative
Returned product consisted of an incomplete device return of an nc emerge balloon catheter.The device was visually and microscopically examined.The hypotube and shaft of the device had numerous kinks.There was a separation of the shaft, 122cm from the strain relief.A total of 16.7cm of inflation lumen was returned and the full returned length of the lumen was stretched down.The guidewire lumen, balloon, markerbands, and tip failed to return for analysis.Product analysis confirmed the reported break as there was separation of the shaft to the device.
Event or Problem Description
It was reported that shaft break occurred.A 4.00mm x 20mm nc emerge balloon catheter was advanced for dilation.However, during procedure, it was noted that the balloon broke off inside the patient.The device was snared and removed intact from the patient.Another balloon was used to complete the procedure.There were no patient complications reported.

• Brand Name: NC 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: 14685384
• Report Number: 2134265-2022-06149
• Device Sequence Number: 5410761
• Product Code: LOX
• UDI-Device Identifier: 08714729846697
• UDI-Public: 08714729846697
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K141236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2022

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: 01/27/2024
• Device Model Number: 7214
• Device Catalogue Number: 7214
• Device Lot Number: 0028756368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/19/2022
• Supplement Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 06/14/2022
• Supplement Report FDA Received Date: 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown