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

Model Number	7213
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was an area of in-stent restenosis lesion in the right coronary artery.A laser was initially used to modify the lesion.A 4.50mm x 15mm nc emerge balloon catheter was advanced and initially inflated at 16 atmospheres.However, during the second inflation at 10 atmospheres (atm) it ruptured.It was replaced with another 4.50mm x 15mm nc emerge but it also ruptured during initial inflation at 14 atm.Subsequently, a 4.50mm x 20mm nc emerge was advanced but also ruptured during the second inflation at 16 atm.The devices were completely removed and the procedure was completed with a wolverine cutting balloon followed by a non-bsc balloon catheter.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
• MDR Report Key: 11369564
• Report Number: 2134265-2021-02261
• Device Sequence Number: 14399446
• Product Code: LOX
• UDI-Device Identifier: 08714729846574
• UDI-Public: 08714729846574
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/23/2021

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: 12/15/2022
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0026520110
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 02/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1