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

Model Number H7493926712400

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 02/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a shaft break occurred.A 4.00mm x 12mm nc emerge balloon catheter was selected for dilation.However, when the balloon was about to insert, the shaft broke in half approximately 80cm from the hub.The device was not used inside the patient.The procedure was completed with another 4.00mm x 12mm emerge balloon catheter.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr: returned product consisted of a nc emerge balloon catheter.There was contrast and blood in the inflation lumen.The balloon was loosely folded.The shaft and hypotube were examined.There were numerous hypotube kinks.The hypotube was fractured 76cm from the hub.The fracture faces were oval as if kinked prior to separation.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).

Event Description

It was reported that a shaft break occurred.A 4.00mm x 12mm nc emerge® balloon catheter was selected for dilation.However, when the balloon was about to insert, the shaft broke in half approximately 80cm from the hub.The device was not used inside the patient.The procedure was completed with another 4.00mm x 12mm 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 - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7362766
• MDR Text Key: 103285685
• Report Number: 2134265-2018-02149
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: H7493926712400
• Device Catalogue Number: 39267-1240
• Device Lot Number: 20498023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2017
• 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