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	03/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.A 5.50mm x 12mm nc emerge balloon catheter was advanced for treatment.However, during advancing across the lesion, the shaft broke inside the sheath.The device was pulled out, and the procedure was completed with another nc emerge balloon.There were no patient complications nor injuries 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 contrast in the loosely folded balloon.There were numerous severe kinks to both the hypotube and the shaft of the device.Distal from the midshaft bond, for a length of 4.2cm, the inflation lumen was stretched.At 3.5cm proximal from the shaft separation, the inflation lumen was stretched.There was a shaft separation at the rapid port exchange (rpe).Distal from the rpe, for a length of 3mm, the shaft was stretched down.At 2mm distal from bicomponent weld, for a length of 3mm, the guidewire lumen was buckled and prolapsed.Product analysis confirmed the reported separation, as there was a shaft separation.
Event or Problem Description
It was reported that shaft break occurred.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.A 5.50mm x 12mm nc emerge balloon catheter was advanced for treatment.However, during advancing across the lesion, the shaft broke inside the sheath.The device was pulled out, and the procedure was completed with another nc emerge balloon.There were no patient complications nor injuries reported.

• Brand Name: NC EMERGE
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16566110
• Report Number: 2124215-2023-12656
• Device Sequence Number: 12185252
• Product Code: LOX
• UDI-Device Identifier: 08714729846468
• UDI-Public: 08714729846468
• Combination Product (Y/N): N
• Initial Reporter State: WY
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2023

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: 08/28/2024
• Device Model Number: 7212
• Device Catalogue Number: 7212
• Device Lot Number: 0030037952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2023
• Supplement Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 03/17/2023
• Supplement Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2022
• 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