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

Model Number 7163

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/14/2021

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event Description

It was reported that the balloon was an incorrect length.The 75% stenosed, straight vessel target lesion was located in the right coronary artery (rca).A 2.50mm x 15mm emerge balloon catheter was advanced to dilate the target lesion.During inflation, the balloon shoulder on the proximal side of the marker band was longer.It was noted to be 1.5 times longer than the proximal marker band.On the distal side, the balloon inflated as expected where the balloon shoulder was at the outer edge of the distal maker band.The procedure was completed successfully with the emerge balloon catheter.No patient complications resulted and the patient was reported to be stable following the procedure.

Manufacturer Narrative

Age at time of event: 18 years or older.Device evaluated by mfr: the returned product consisted of an emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was contrast in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.Microscopic inspection revealed tip damage.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There were no defects detected.The balloon length measured 15mm.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis did not confirm the reported balloon length issue.

Event Description

It was reported that the balloon was an incorrect length.The 75% stenosed, straight vessel target lesion was located in the right coronary artery (rca).A 2.50mm x 15mm emerge balloon catheter was advanced to dilate the target lesion.During inflation, the balloon shoulder on the proximal side of the marker band was longer.It was noted to be 1.5 times longer than the proximal marker band.On the distal side, the balloon inflated as expected where the balloon shoulder was at the outer edge of the distal maker band.The procedure was completed successfully with the emerge balloon catheter.No patient complications resulted and the patient was reported to be stable following the procedure.

• Brand Name: EMERGE
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11778633
• MDR Text Key: 249217853
• Report Number: 2134265-2021-05679
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2023
• Device Model Number: 7163
• Device Catalogue Number: 7163
• Device Lot Number: 0026822172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Date Manufacturer Received: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1