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	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/08/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture occurred.The 70% stenosed, target lesion was located in a calcified vessel.A 4.50mm x 15mm nc emerge balloon catheter was advanced for post dilatation of a synergy drug-eluting stent.However, during inflation at 22 atmospheres, the balloon ruptured.When the device was removed from the patient, it looked like a piece of the balloon was missing.No balloon fragments were found via fluoroscopy but the physician thought a piece remained in the patient.All devices were removed from the patient and the procedure was not completed.No patient complications were reported.
Additional Manufacturer Narrative
Maude report.
Event or Problem Description
It was further reported that this is the same case as user facility maude report #mw5098430.It was reported that balloon rupture occurred.The 70% stenosed, target lesion was located in a calcified vessel.A 4.50mm x 15mm nc emerge balloon catheter was advanced for post dilatation of a synergy drug-eluting stent.However, during inflation at 22 atmospheres, the balloon ruptured.When the device was removed from the patient, it looked like a piece of the balloon was missing.No balloon fragments were found via fluoroscopy but the physician thought a piece remained in the patient.All devices were removed from the patient and the procedure was not completed.No patient complications were reported.
Event or Problem Description
It was further reported that this is the same case as user facility maude report #mw5098430 it was reported that balloon rupture occurred.The 70% stenosed, target lesion was located in a calcified vessel.A 4.50mm x 15mm nc emerge balloon catheter was advanced for post dilatation of a synergy drug-eluting stent.However, during inflation at 22 atmospheres, the balloon ruptured.When the device was removed from the patient, it looked like a piece of the balloon was missing.No balloon fragments were found via fluoroscopy but the physician thought a piece remained in the patient.All devices were removed from the patient and the procedure was not completed.No patient complications were reported.
Additional Manufacturer Narrative
Maude report: device evaluated by mfr: returned product consisted of an nc emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was a complete separation of the inner shaft 3mm distal of the distal marker band.There was no tip or distal portion of balloon.There was contrast and blood in the inflation lumen, and blood in the guidewire lumen.The balloon was loosely folded.There was a circumferential tear 10mm from the proximal end of the balloon.The inner shaft was stretched for 10mm starting 30mm from the proximal marker band.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 11039902
• Report Number: 2134265-2020-18009
• Device Sequence Number: 16460113
• Product Code: LOX
• UDI-Device Identifier: 08714729846574
• UDI-Public: 08714729846574
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup,Followup
• Report Date (Section B): 03/02/2021

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: 09/26/2021
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0024502575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 01/14/2021; 02/05/2021
• Initial Report FDA Received Date: 12/18/2020
• Supplement Report FDA Received Date: 01/27/2021; 03/02/2021
• 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