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

Model Number H7493919015150

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Hematoma (1884)

Event Date 10/26/2021

Event Type  Injury  

Event Description

Pt mr# (b)(6), had an lhc via right radial artery.Disease noted in mid lad and diagonal branch.The physician poba (ballooned) the lad times five with the boston scientific emerge push 2.0mm x 20mm.Md advanced without difficulty, no excessive force noted, while moving into the diagonal with an emerge 1.5 mm x 15mm, the balloon detached in the artery.Attempted to remove the balloon with a gooseneck snare, unsuccessful.Md attempted to inflate the balloon in the guide in order to remove the detached balloon, unsuccessful.Inadvertently, the boston scientific emerge 2.00 x 20 mm detached in the guide in the right arm.Pt became hemodynamically instable, iabp inserted in right femoral artery.Impella team called.Pt received two stents to the mid lad.Impella inserted and iabp removed.Pt transported via ems to a higher level of care for urgent retrieval of balloons.Upon accepting the pt at a tertiary hospital, the pt required vascular surgery for removal of angioplasty balloon in the diagonal artery, angioplasty balloon recovered and c1v performed to distal diagonal hematoma and right artery ligation.Both balloons were retrieved.At (b)(6) hosp, all euphora emergepush 1.5 mm x 15mm and all emerge 2.0mmx20mm were removed off the shelves.Boston rep, (b)(4) was informed of this event.All (b)(6) facilities were notified and these products were removed and replaced.

• Brand Name: EMERGE PUSH
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12752219
• MDR Text Key: 280526019
• Report Number: MW5105145
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/02/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H7493919015150
• Device Lot Number: 27241842
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White