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

Model Number H7493919312400

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

Patient Problem Death (1802)

Event Date 07/14/2018

Event Type  Death  

Manufacturer Narrative

Device evaluated by mfr.: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.  bsc id: (b)(4).Tw: (b)(4).

Event Description

It was reported that patient died.Vascular access was obtained via the femoral artery.The 15mm x 4.20mm, eccentric, de novo, target lesion was located in the moderately tortuous, mildly calcified unprotected left main artery with a significant bend greater than 90 degrees.A 4.00mm x 12mm emerge¿ balloon catheter was selected to treat the lesion.However, due to patient high risk, and although cardiopulmonary resuscitation was performed, the patient died after the procedure.

Manufacturer Narrative

Describe event or problem updated.(b)(4).

Event Description

It was further reported that the patient presented with myocardial infarction (mi).During the procedure, a non-bsc stent was implanted and the procedure was successfully completed.Post procedure, the patient was admitted to the intensive coronary care unit for observation.However, two days later, the patient became uncomfortable and the patient's pressures started dropping and the patient subsequently died after a couple of minutes.The physicians diagnosed that the patient died due to severe repeated mi.Per physician's opinion, the emerge balloon was not directly related to the patient's death because the procedure was successful and the patient died later.Autopsy was not performed.

• 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: 7766896
• MDR Text Key: 116535169
• Report Number: 2134265-2018-07030
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K113220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: H7493919312400
• Device Catalogue Number: 39193-1240
• Device Lot Number: 20431975
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2017
• 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
• Patient Outcome(s): Death
• Patient Age: 63 YR
• Patient Weight: 61