MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE NC EMERGE® CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number H7493926712300

Device Problem Kinked (1339)

Patient Problem No Patient Involvement (2645)

Event Date 03/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4). Device evaluated by mfr: returned product consisted of an nc emerge balloon catheter. The balloon was loosely folded. There was contrast in the inflation lumen. The outer shaft, inner shaft, balloon and tip were microscopically examined. The hypotube shaft was completely separated 30 cm from the hub and 65 cm from the tip. The fracture faces were oval as if kinked prior to separation. There were numerous hypotube kinks. There was tip damage. There was no evidence of any material or manufacturing deficiencies contributing to the damage. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The most probable root cause is considered handling damage as the event occurred without direct patient contact. (b)(4).

Event Description

Reportable based on analysis completed on 21-apr-2017. It was reported that shaft kink occurred. A 3. 00mm x 12mm nc emerge® balloon catheter was selected for dilation. Outside of the patient's body, one of the technicians prepared the device and kinked its shaft. The procedure was completed with a different device. No patient complications were reported. However, returned device analysis revealed a hypotube break.

• Brand Name: NC EMERGE®
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6530745
• MDR Text Key: 74047450
• Report Number: 2134265-2017-04493
• Device Sequence Number: 1
• Product Code: LOX
• 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

• Type of Report: Initial
• Report Date: 04/21/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/31/2019
• Device Model Number: H7493926712300
• Device Catalogue Number: 39267-1230
• Device Lot Number: 20225841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial