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

Model Number	7212
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: the event date was note reported.The first date of the month of the aware date was entered as an estimate.
Event or Problem Description
It was reported that shaft break occurred.A 3.50mm x 12mm nc emerge balloon catheter was advanced for dilation.However, while pushing through the sheath, the shaft break.The procedure was completed with another of same device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
B3 date of event - corrected from 08/01/2021 to 08/19/2021.B5.Describe event or problem- corrected and updated.
Event or Problem Description
It was reported that shaft break occurred.A 3.50mm x 12mm nc emerge balloon catheter was advanced for dilation.However, while pushing through the sheath, the shaft break.The procedure was completed with another of same device.There were no patient complications nor injuries reported.It was further reported that the condition of the patient is fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an nc emerge balloon catheter.The device was visually and microscopically examined.The hypotube of the device has numerous kinks.There was a hypotube separation 56.5cm from the strain relief.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded with blood and contrast present in the balloon folds.
Event or Problem Description
It was reported that shaft break occurred.A 3.50mm x 12mm nc emerge balloon catheter was advanced for dilation.However, while pushing through the sheath, the shaft break.The procedure was completed with another of same device.There were no patient complications nor injuries reported.It was further reported that the condition of the patient is fine.

• 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: 12367582
• Report Number: 2134265-2021-10809
• Device Sequence Number: 4333230
• Product Code: LOX
• UDI-Device Identifier: 08714729846413
• UDI-Public: 08714729846413
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/07/2022

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: 06/18/2023
• Device Model Number: 7212
• Device Catalogue Number: 7212
• Device Lot Number: 0027516513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/19/2021
• Supplement Date Received by Manufacturer: 08/24/2021; 03/02/2022
• Initial Report FDA Received Date: 08/25/2021
• Supplement Report FDA Received Date: 08/31/2021; 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2021
• 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
• Patient Sex: Unknown