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

Model Number 7214

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 01/26/2021

Event Type  malfunction  

Event Description

It was reported that detachment occurred.A 2.50mm x 20mm nc emerge balloon catheter was selected for use.However, during procedure, it was noticed that the balloon came right off the shaft of the guide.The procedure was completed with another of same device.No patient complications nor injuries were reported.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of an nc emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was a complete separation at 86cm distal of the strain relief.There was contrast in the inflation lumen, and blood in the guidewire lumen.The balloon was tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that detachment occurred.A 2.50mm x 20mm nc emerge balloon catheter was selected for use.However, during procedure, it was noticed that the balloon came right off the shaft of the guide.The procedure was completed with another of same device.No patient complications nor injuries 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
• MDR Report Key: 11310570
• MDR Text Key: 231341344
• Report Number: 2134265-2021-01099
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729846635
• UDI-Public: 08714729846635
• 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: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/25/2022
• Device Model Number: 7214
• Device Catalogue Number: 7214
• Device Lot Number: 0026420282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Date Manufacturer Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1