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

Model Number 7312

Device Problems Break (1069); Material Rupture (1546); Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 12/29/2020

Event Type  Injury  

Event Description

It was reported that a balloon rupture, balloon detachment, shaft break and additional intervention occurred.A percutaneous coronary intervention was being performed on a focal in-stent stenosis in the proximal left anterior descending (lad) coronary artery.A jl3.5 guiding catheter was used with a non-boston scientific guidewire in the distal lad.Intravascular ultrasound (ivus) was used.The lesion was predilated twice with a 3.5mm x 12mm nc emerge balloon up to 30 atmospheres.After the second dilation the balloon ruptured.The balloon did not recoil easily and broke off at the distal shaft level.The balloon remained in the left main.The balloon was trapped with a 2.0mm balloon and removed from the left main and positioned in the right radial.The balloon residue was too large to remove via the sheath and also too large to be removed without a sheath.A gooseneck snare was used to remove the remainder of the balloon and balloon shaft.The device was completely removed from the patient and the procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: NC 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: 11207805
• MDR Text Key: 227979283
• Report Number: 2134265-2021-00446
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2022
• Device Model Number: 7312
• Device Catalogue Number: 7312
• Device Lot Number: 0026156890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention