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

Model Number H7493926708350

Device Problems Detachment Of Device Component (1104); Material Rupture (1546); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Returned product consisted of a nc emerge balloon catheter in two pieces along with 2 unidentified y-adapters and an unidentified 7f guide catheter.The balloon was loosely folded with blood in the guidewire lumen.The outer shaft, inner shaft, balloon and tip were microscopically examined.The outer shaft is torn/separated 140.9cm from the hub and the inner shaft is torn/separated 2mm from the exit notch.The fractured/separated ends of the shafts are stretched and jagged which indicates the shaft separation was due to tensile forces.There are numerous hypotube and shaft kinks.The tip and balloon have been torn off/separated and were not returned for analysis.The distal inner shaft is buckled and stretched in numerous locations.There was no evidence of any material or manufacturing deficiencies contributing to the confirmed damage or event.The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

Same case as mdr id 2134265-2018-05363.It was reported that balloon rupture and detachment occurred.The chronic totally occluded target lesion was located in the right coronary artery.A 3.50mm x 8mm nc emerge® balloon catheter was advanced for dilation.However, during the procedure, the balloon ruptured in the artery.Upon removal of the device, it was believed that the balloon snagged on the 7f guidezilla¿ ii guide extension catheter.The balloon then detached from the shaft of the balloon.The balloon was completely removed by pulling the guide wire and guidezilla.Then aspiration was performed to remove the balloon fragments.No damage was noted on the guidezilla.The procedure was then completed with new emerge balloons and synergy stents.No further patient complications were reported and the patient's status was good.

• 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: 7602164
• MDR Text Key: 111083814
• Report Number: 2134265-2018-05362
• 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
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2020
• Device Model Number: H7493926708350
• Device Catalogue Number: 39267-0835
• Device Lot Number: 0021945196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2018
• 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
• Patient Outcome(s): Required Intervention