MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number 7133

Device Problem Material Rupture (1546)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Pain (1994)

Event Date 02/14/2022

Event Type  Injury  

Event Description

It was reported that balloon rupture occurred; the patient experienced bradycardia, decreased blood pressure, and pain. The patient underwent vascular dilatation by intervention. The 95% stenosed target lesion was located in the mildly tortuous and severely calcified proximal, mid and distal right coronary artery. A 2. 50mm x 15mm emerge balloon catheter was advanced for dilatation and was inflated at 14 atmospheres. It was noted that the balloon burst due to severe calcification. The physician found a circular, with no image in the middle and distal segment of the patient's blood vessels, the patient suddenly developed a slowed heart rate, decreased blood pressure, pain, and moaning/groaning symptoms. Atropine, epinephrine, dopamine, morphine injection and other intravenous injections were given immediately to the patient. No further patient complications were reported and the patient was stable.

• Brand Name: EMERGE
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13725881
• MDR Text Key: 287112392
• Report Number: 2134265-2022-02255
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K113220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 7133
• Device Catalogue Number: 7133
• Device Lot Number: 0027557373
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/10/2022 Patient Sequence Number: 1