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

Model Number 7311

Device Problems Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/31/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Device evaluated by mfr.: the device was returned for analysis.The shaft, hypotube, tip and balloon were microscopically and visually examined.Upon visual and microscope examination of the shaft, hypotube, tip and balloon.There were numerous kinks noted.There was a complete separation at 81.2cm distal of the strain relief.There was contrast in the inflation lumen and balloon.The balloon was loosely folded.Microscopic inspection revealed tip damage.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

Reportable based on device analysis completed on 16oct2020.It was reported that a shaft kinked had occurred.The 90% stenosed lesion was severely tortuosed and severely calcified.An 3.00mm x 8.00mm nc emerge balloon was selected for use.During the procedure, it was noted that the shaft was kinked.The procedure was completed with a different device.No patient complications were reported.However, device analysis noted a complete separation at 81.2cm distal of the strain relief.

• 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: 10801956
• MDR Text Key: 215088802
• Report Number: 2134265-2020-15461
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2022
• Device Model Number: 7311
• Device Catalogue Number: 7311
• Device Lot Number: 0025259560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2020
• 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