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	08/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred, the patient presented with st-segment elevation myocardial infarction (stemi) and underwent left heart catheterization (lhc).The target lesion was located in a non-calcified vessel.A 4.50mm x 12mm nc emerge balloon catheter was advanced for dilatation.However, during inflation at 14 atmospheres, the balloon burst.The device was completely removed and the procedure was completed with an unspecified device.No patient complications were reported.
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented with st-segment elevation myocardial infarction (stemi) and underwent left heart catheterization (lhc).The target lesion was located in a non-calcified vessel.A 4.50mm x 12mm nc emerge balloon catheter was advanced for dilatation.However, during inflation at 14 atmospheres, the balloon burst.The device was completely removed and the procedure was completed with an unspecified device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an nc emerge balloon catheter.The device was visually and microscopically examined.There was contrast and blood in the inflation lumen.There was blood in the guidewire lumen and the balloon was loosely folded and had contrast.There was a longitudinal tear 8mm in length, 4mm from the tip of the device.Product analysis confirmed the reported event, as the device had a longitudinal tear in the balloon.

• 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: 15331860
• Report Number: 2124215-2022-33563
• Device Sequence Number: 6478875
• Product Code: LOX
• UDI-Device Identifier: 08714729846444
• UDI-Public: 08714729846444
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2022

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: 04/06/2024
• Device Model Number: 7212
• Device Catalogue Number: 7212
• Device Lot Number: 0029189951
• 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: 08/25/2022
• Supplement Date Received by Manufacturer: 09/26/2022
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2022
• 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