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

Model Number 7133

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Hematoma (1884)

Event Date 10/26/2021

Event Type  Injury  

Event Description

It was reported via medwatch mw5105145 that balloon detachment occurred, requiring surgery for removal vascular presented for left heart catheterization via the right radial artery.Disease was noted in the mid left anterior descending artery (lad) and the diagonal branch.The physician ballooned the lad five times with a 2.00mm x 20mm emerge push balloon.The 2.5mm x 15mm emerge balloon was advanced without difficulty, no excess force was noted but while moving into the diagonal, the balloon detached in the artery.An attempt was made to snare the balloon but it was unsuccessful.The physician attempted to inflate the balloon in the guide in order to remove the detached balloon but this was also unsuccessful.Inadvertently the 2.00 x 20mm emerge push balloon detached in the guide in the right arm.The patient became hemodynamically unstable and an intra-aortic balloon pump was inserted in right femoral artery.The patient received two stents to the mid lad and a ventricular assist device was inserted and then removed.The patient was transported to a higher level of care for urgent retrieval of the balloons.The patient underwent vascular surgery and both balloons were retrieved.The distal diagonal hematoma was also treated as well as right artery ligation.

• 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: 13122357
• MDR Text Key: 283591093
• Report Number: 2134265-2021-16371
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729806196
• UDI-Public: 08714729806196
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2024
• Device Model Number: 7133
• Device Catalogue Number: 7133
• Device Lot Number: 0027661574
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2021
• 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): Required Intervention