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

Model Number	7213
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The patient was presented with cardiovascular artery disease and underwent percutaneous coronary intervention.The 90% stenosed target lesion was located in moderate to severely calcified and tortuous left anterior descending artery (lad) as well as radial artery.A 3.75mm x 12mm, 3.75mm x 20mm, 3.75mm x 12mm, and 3.75mm x 15mm nc emerge balloon catheters were used.However, the shaft of the four catheters were badly bent and broken.The devices were both pulled out intact from the patient's body.The procedure was completed different balloon.There were no patient complications reported.
Event or Problem Description
It was reported that shaft break occurred.The patient was presented with cardiovascular artery disease and underwent percutaneous coronary intervention.The 90% stenosed target lesion was located in moderate to severely calcified and tortuous left anterior descending artery (lad) as well as radial artery.A 3.75mm x 12mm, 3.75mm x 20mm, 3.75mm x 12mm, and 3.75mm x 15mm nc emerge balloon catheters were used.However, the shaft of the four catheters were badly bent and broken.The devices were both pulled out intact from the patient's body.The procedure was completed different balloon.There were no patient complications 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 a separation of the hypotube 24.7cm from the strain relief.The separated ends were ovaled in shape indicating the device was kinked prior to separation.There were numerous kinks to the hypotube.There was contrast in the inflation lumen and blood in the guidewire lumen.There was blood within the tight folds of the tightly folded balloon.Product analysis confirmed the reported events as there was separation and kinks to the hypotube of the device.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16090912
• Report Number: 2124215-2022-55786
• Device Sequence Number: 17818796
• Product Code: LOX
• UDI-Device Identifier: 08714729846550
• UDI-Public: 08714729846550
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 01/26/2023

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: 05/07/2024
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0029358714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2022
• Supplement Date Received by Manufacturer: 01/23/2023
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 01/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2022
• 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