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

Model Number 7213

Device Problem Material Rupture (1546)

Patient Problem Insufficient Information (4580)

Event Date 06/02/2021

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred.A 2.50mm x 15mm nc emerge balloon catheter was advanced for dilatation.However, during second inflation, the balloon ruptured.No further patient complications were reported.

Event Description

It was reported that balloon rupture occurred.A 2.50mm x 15mm nc emerge balloon catheter was advanced for dilatation.However, during second inflation, the balloon ruptured.No further patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of an nc emerge balloon catheter.The device was microscopically and visually examined.There was contrast in the inflation lumen and balloon.There was blood in the guidewire lumen and balloon.The balloon was loosely folded, and the device had tip damage.The device was soaked for a period of time and then prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There was a pinhole in the balloon located 7mm from the tip of the device.The device failed to inflate to rated burst pressure.Product analysis confirmed the reported event, as the device was found to have a pinhole damage to the balloon.

• 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
• MDR Report Key: 12027042
• MDR Text Key: 257223630
• Report Number: 2134265-2021-07864
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729846505
• UDI-Public: 08714729846505
• Combination Product (y/n): N
• PMA/PMN Number: K141236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2023
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0027046229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Date Manufacturer Received: 07/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1