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

Model Number UNK731

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

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Cardiogenic Shock (2262)

Event Date 09/21/2017

Event Type  Death  

Manufacturer Narrative

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.(b)(4).

Event Description

Same case as mdr#2134265-2017-10152.It was reported that loss of blood pressure, cardiogenic shock, and death occurred.The patient presented with almost no-flow in the right coronary artery (rca).In the physician¿s opinion the patient¿s vessel condition was bad and the patient could not undergo surgery.The 95-99% stenosed target lesion was located in the left anterior descending artery (lad).During the first pre-dilatation with an nc emerge balloon, the patient's blood pressure suddenly dropped.The patient was given vasopressors and a 2.5x20mm synergy stent was implanted in the left main over the lad in an attempt to increase the blood flow.The patient's blood pressure did not improve and cardiopulmonary resuscitation was performed for an hour.The patient went into cardiogenic shock and died.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported there was no allegation against this device.The balloon used in the procedure was a non-bsc device and not an emerge balloon as was previously reported.

• 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: 6912613
• MDR Text Key: 88101924
• Report Number: 2134265-2017-09964
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K113220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK731
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 69 YR