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

Model Number	7213
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Deportable based on device analysis completed on 30-dec-2021.It was reported that shaft kink and advancing difficulties were encountered.The target lesion was located in a coronary artery.A 3.25mm x 15mm nc emerge balloon catheter was advanced for dilatation.However, during insertion, the physician noted that the shaft was breaking with even gentle flexion applied and was breaking in many places.The balloon failed to advance as it was bending in multiple places along the shaft.The device was removed intact and the procedure was completed with a different device.No patient complications were reported.However, returned device analysis revealed a hypotube separation.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an nc emerge balloon catheter.Photo media review showed multiple separations to the device and an estimated 4 total parts to the device.The overall length of the device is 143cm +/- 5cm.The total length of device returned was 100cm in total.The device was visually and microscopically examined.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded.At 44.8cm from the strain relief, the hypotube was separated.The separated ends of the hypotube were ovaled in shape indicating the device was kinked prior to separation.The hypotube separation would prevent the device from advancing during use.

• 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: 13311399
• Report Number: 2134265-2022-00234
• Device Sequence Number: 4934092
• Product Code: LOX
• UDI-Device Identifier: 08714729846536
• UDI-Public: 08714729846536
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Report Date (Section B): 01/20/2022

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: 06/10/2023
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0027466329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/30/2021
• Initial Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2021
• 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