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

Model Number	7213
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 3.50mm x 15mm nc emerge balloon catheter was advanced for dilatation.However, during the procedure, the balloon fractured.The broken component was able to be retrieved from the patient's body and the procedure was completed with another balloon.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of an fg nc emerge mr, us 3.50mm x 15mm balloon.The device was visually and microscopically examined.There was contrast in the inflation lumen.The balloon was tightly folded.There was blood in the guidewire lumen.Product analysis could confirm the reported event, there was a hypotube separation 50.8cm from the strain relief.Further analysis identified multiple kinks along the hypotube and shaft of the device.No other device issues noted during analysis.
Event or Problem Description
It was reported that shaft break occurred.A 3.50mm x 15mm nc emerge balloon catheter was advanced for dilatation.However, during the procedure, the balloon fractured.The broken component was able to be retrieved from the patient's body and the procedure was completed with another balloon.There were no patient complications 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; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19217761
• Report Number: 2124215-2024-24205
• Device Sequence Number: 15514339
• Product Code: LOX
• UDI-Device Identifier: 08714729846543
• UDI-Public: 08714729846543
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2024

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: 11/28/2025
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0032954791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/10/2024
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2023
• 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