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

Model Number	7213
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: the returned product consisted of an nc emerge balloon catheter.The device was microscopically and visually examined.The hypotube of the device has numerous kinks.There was a separation 56.7cm from the strain relief.There was both contrast and blood in the inflation lumen and balloon.There was contrast present in the guidewire lumen.The balloon was tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon detachment occurred.The 95% stenosed target lesion was located in the non-tortuous and moderately calcified proximal left anterior descending artery.A 4.00mm x 15mm nc emerge balloon catheter was selected for use.During insertion of the balloon catheter through the guider, the balloon never made it past the curve of arch.The proximal half was removed as normal through the touhy and visualized under fluoro prior to removal of guider and guidewire.The guider was flushed which did not eject portion of balloon catheter.The distal end remained in the guider and guide/guidewire.A guidewire was inserted through the guider which pushed the remainder of the balloon catheter out of guider.The remaining portion were removed as one unit.The two portions of balloon catheter were inspected and appeared intact; the shear was in mid catheter.The device was completely removed and the procedure was completed with a new 4x15 nc emerge balloon catheter.No patient complications were reported.

• 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
• MDR Report Key: 11913372
• Report Number: 2134265-2021-06897
• Device Sequence Number: 17200153
• Product Code: LOX
• UDI-Device Identifier: 08714729846567
• UDI-Public: 08714729846567
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/01/2021

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: 02/12/2023
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0026798710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 06/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1