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

Model Number 7311

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/14/2019

Event Type  malfunction  

Event Description

It was reported that shaft break occurred.A 2.50mm x 8mm nc emerge balloon catheter was selected for use.However, it was noted that the balloon broke into two parts at the output of the catheter sheath.No known patient complications were reported.

Event Description

It was reported that shaft break occurred.A 2.50mm x 8mm nc emerge balloon catheter was selected for use.However, it was noted that the balloon broke into two parts at the output of the catheter sheath.No known patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a nc emerge balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks along the hypotube.The hypotube is separated 79.2cm from the hub.Microscopic examination revealed no additional damages.The balloon is still tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 8492844
• MDR Text Key: 141242354
• Report Number: 2134265-2019-03565
• 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: 05/23/2019

1 Device was Involved in the Event

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 Expiration Date: 10/25/2020
• Device Model Number: 7311
• Device Catalogue Number: 7311
• Device Lot Number: 0022849529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Initial Date Manufacturer Received: 03/19/2019
• Initial Date FDA Received: 04/08/2019
• Supplement Dates Manufacturer Received: 05/02/2019
• Supplement Dates FDA Received: 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1