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

Model Number 7213

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/13/2021

Event Type  malfunction  

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 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
• Type of Device: 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: 11913372
• MDR Text Key: 253526841
• Report Number: 2134265-2021-06897
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729846567
• UDI-Public: 08714729846567
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2021
• Initial Date FDA Received: 06/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1