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

Model Number	7213
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 80-90% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending.A 2.75mm x 15mm nc emerge balloon catheter was advanced for dilatation.However, during introduction, the shaft broke outside the body.The device was removed manually, and the procedure was completed with another similar device.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that shaft break occurred.The 80-90% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending.A 2.75mm x 15mm nc emerge balloon catheter was advanced for dilatation.However, during introduction, the shaft broke outside the body.The device was removed manually, and the procedure was completed with another similar device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Updated h6: device codes.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 47.5cm from the strain relief.There were numerous kinks to the hypotube of the device.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded.Product analysis confirmed the reported separation, as there was a hypotube separation.There were also numerous unreported hypotube kinks to the device.The reported no cross in the lesion could not be confirmed as the clinical circumstances could not be replicated.

• 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: 18019951
• Report Number: 2124215-2023-58839
• Device Sequence Number: 7696394
• Product Code: LOX
• UDI-Device Identifier: 08714729846512
• UDI-Public: 08714729846512
• Combination Product (Y/N): N
• 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): 11/23/2023

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: 05/24/2025
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0031691726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/19/2023
• Supplement Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 10/27/2023
• Supplement Report FDA Received Date: 11/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2023
• 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