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

Model Number	7133
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	10/26/2021
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: 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
• Report Number: 2134265-2021-16371
• Device Sequence Number: 17309580
• Product Code: LOX
• UDI-Device Identifier: 08714729806196
• UDI-Public: 08714729806196
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K113220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2021
• Initial Report FDA Received Date: 12/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown