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

Model Number 7314

Device Problems Break (1069); Material Deformation (2976)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2020

Event Type  malfunction  

Event Description

It was reported that shaft break occurred a 2.75 mm x 20 mm nc emerge balloon catheter was selected for use and it was noted that the catheter was kinked.During introducing the balloon catheter over the wire, the catheter shaft broke on a portion outside the patients body.The procedure was completed with another of the same device.No patient complications were reported.

Event Description

It was reported that shaft break occurred.A 2.75 mm x 20 mm nc emerge balloon catheter was selected for use and it was noted that the balloon was already kinked.During introducing the balloon over the wire, the shaft of the balloon broke outside patient's body.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Device evaluation 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 12.3cm distal of the strain relief.There was blood in the guidewire lumen.The balloon was 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: 11015721
• MDR Text Key: 221825714
• Report Number: 2134265-2020-17861
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 03/10/2021

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: 07/16/2021
• Device Model Number: 7314
• Device Catalogue Number: 7314
• Device Lot Number: 0024119886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 02/19/2021
• Supplement Dates FDA Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 80