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

Model Number H7493926720200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 11/18/2016

Event Type  Death  

Manufacturer Narrative

The device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).

Event Description

Same case as mdr id: 2134265-2016-11336; 2134265-2016-11338; 2134265-2016-11339; 2134265-2016-11340; 2134265-2016-11343; 2134265-2016-11355; 2134265-2016-11341; 2134265-2016-11342; 2134265-2016-11380; 2134265-2016-11378; 2134265-2016-11379.It was reported that patient death occurred.The target lesion was located in the left anterior descending artery.During testing of a 1.50mm rotalink¿ plus and rotawire guide wire with the rotablator console and a dynaglide foot pedal, the system baseline tested "okay" outside the patient.Rotational atherectomy was performed however, the burr stopped spinning and a hissing noise was noted from the nitrogen tank to the console.It was further reported atherectomy was discontinued and several boston scientific balloons and stents were utilized.The patient expired.Additional information was requested but not available.

• 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: 6196401
• MDR Text Key: 63050074
• Report Number: 2134265-2016-11337
• 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: 11/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: H7493926720200
• Device Catalogue Number: 39267-2020
• Device Lot Number: 19714265
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2016
• 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): Death