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

Model Number	7212
Medical Device Problem Codes	Break (1069); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a balloon rupture and shaft break occurred.A 2.50mm x 12mm nc emerge balloon catheter was selected for use.During insertion the balloon ruptured as blood was observed within the inflation device.When attempting to remove the emerge balloon the shaft detached.Another balloon catheter was used to trap the wire part of the emerge balloon catheter and the detached shaft was retrieved from the patient.The procedure was completed with another balloon catheter.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.At 50.2cm from the strain relief, the hypotube was separated.The separated ends were ovaled in shape indicating the device was kinked prior to separation.There were numerous kinks to the hypotube and shaft.There was contrast and blood in the inflation lumen and blood in the guidewire lumen.The balloon was loosely folded and had contrast.A touhy was attached to the separated end of the distal portion of the device, then attached to an inflation device filled with water and was inflated to rated burst pressure.The balloon was able to be inflated to rated burst pressure, as well as deflate with no issues.Product analysis did not confirm the reported burst, as during functional testing the balloon inflated to rated burst pressure and deflated with no issues.The reported separation was confirmed as the hypotube of the device was separated.
Event or Problem Description
It was reported that a balloon rupture and shaft break occurred.A 2.50mm x 12mm nc emerge balloon catheter was selected for use.During insertion the balloon ruptured as blood was observed within the inflation device.When attempting to remove the emerge balloon the shaft detached.Another balloon catheter was used to trap the wire part of the emerge balloon catheter and the detached shaft was retrieved from the patient.The procedure was completed with another balloon catheter.No patient complications were 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12919104
• Report Number: 2134265-2021-15259
• Device Sequence Number: 20079424
• Product Code: LOX
• UDI-Device Identifier: 08714729846376
• UDI-Public: 08714729846376
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 01/13/2022

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: 08/12/2023
• Device Model Number: 7212
• Device Catalogue Number: 7212
• Device Lot Number: 0027824550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2021
• Supplement Date Received by Manufacturer: 12/30/2021
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2021
• 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