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

Model Number 7313

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6). Device evaluated by mfr. : returned product consisted of an nc emerge balloon catheter. The shaft, hypotube, tip and balloon were microscopically and visually examined. There were numerous kinks. There was a complete separation at 56. 7cm distal of the strain relief. The balloon was tightly folded. Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

Reportable based on device analysis completed on 16dec2019. It was reported that shaft kink occurred. A 2. 25mm x 15mm nc emerge balloon catheter was selected for use. However, the device could not be loaded over the guide wire due to kink in the shaft. The procedure was completed with a different device. No patient complications were reported. However, returned device analysis revealed shaft detachment.

• 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: 9526715
• MDR Text Key: 177146004
• Report Number: 2134265-2019-16156
• 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

• Type of Report: Initial
• Report Date: 12/27/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/19/2021
• Device Model Number: 7313
• Device Catalogue Number: 7313
• Device Lot Number: 0023817480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial