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

Model Number H7493918920200

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

Patient Problem Death (1802)

Event Date 03/07/2018

Event Type  Death  

Manufacturer Narrative

Device evaluated by mfr: the device was not returned for analysis.The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).

Event Description

Same case as mdr id#: 2134265-2018-02521, 2134265-2018-02525, 2134265-2018-02531, 2134265-2018-02523 and 2134265-2018-02530.It was reported that the patient died.The 90% stenosed target lesion was located in the left circumflex artery.After an 8f mach1 guide catheter was advanced, a 1.50mm peripheral rotalink® plus and a 330cm rotawire were advanced for ablation.However, during the procedure, it was noted that the burr became stuck in the plaque of the artery.Intracardiac nitroglycerin was then administered and the vessel was rewired.Subsequently, dilatations were performed with a 1.20mm x 12mm, 2.00mm x 20mm, and 2.5mm x 15mm emerge¿ balloon catheters to facilitate removal of the burr but were unsuccessful.The physician decided to perform coronary artery bypass graft on the patient and the burr was successfully removed.The patient was then transferred to the intensive care unit; however, 1 hour and 26 minutes later, the patient died.

• Brand Name: 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: 7389434
• MDR Text Key: 104086183
• Report Number: 2134265-2018-02522
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113220
• 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: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2020
• Device Model Number: H7493918920200
• Device Catalogue Number: 39189-2020
• Device Lot Number: 0021656286
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2018
• 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): Death