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

Model Number	7212
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a mildly tortuous and non-calcified proximal vessel.A 2.50mm x 12mm nc emerge balloon catheter was advanced for treatment.However, prior to inflation, it was noticed that there was blood in the hub.The balloon was still inflated but did not hold inflation for a long period of time.It was noted that the balloon ruptured, and nothing was detached.The balloon was removed intact and the procedure was completed.There were no patient complications reported.
Additional Manufacturer Narrative
Returned product consisted of the nc emerge balloon catheter.The shafts, tip, balloon, and markerbands were microscopically and visually examined.There was contrast and blood in the inflation lumen and balloon with blood in the guidewire lumen.The balloon was loosely folded.Inspection of the device revealed that majority of the inflation lumen and the wire lumen were buckled, and the tip was damaged.When the balloon was inspected there was a hole with bunched up material revealed at the proximal balloon transition.The markerbands were microscopically examined and there were no damage or irregularities.Product analysis confirmed the reported balloon burst, as there was a hole in the balloon.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a mildly tortuous and non-calcified proximal vessel.A 2.50mm x 12mm nc emerge balloon catheter was advanced for treatment.However, prior to inflation, it was noticed that there was blood in the hub.The balloon was still inflated but did not hold inflation for a long period of time.It was noted that the balloon ruptured, and nothing was detached.The balloon was removed intact and the procedure was completed.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: 16041955
• Report Number: 2124215-2022-54536
• Device Sequence Number: 5237635
• Product Code: LOX
• UDI-Device Identifier: 08714729846376
• UDI-Public: 08714729846376
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2023

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: 10/19/2024
• Device Model Number: 7212
• Device Catalogue Number: 7212
• Device Lot Number: 0030382292
• 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: 12/16/2022
• Supplement Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 12/23/2022
• Supplement Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2022
• 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