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

Model Number 7312

Device Problem Material Rupture (1546)

Patient Problem Vascular Dissection (3160)

Event Date 11/19/2018

Event Type  Injury  

Event Description

It was reported that balloon rupture and vessel dissection occurred.The target lesion was located in a coronary artery.A 2.50mm x 12mm nc emerge balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured and a vessel dissection "were" also noted.No patient complications were reported.

Event Description

It was reported that balloon rupture and vessel dissection occurred.The target lesion was located in a coronary artery.A 2.50mm x 12mm nc emerge balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured and a vessel dissection were also noted.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a nc emerge balloon catheter with a 0.014 guidewire stuck inside the device.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks along the whole device.The inflation lumen is separated 130.1cm from the hub.The distal section of the separation appears to have been stretched prior to separation.Microscopic examination revealed that the balloon is torn circumferentially and the distal section is missing.There is a longitudinal tear in the balloon.From the separation going proximal it is approximately 4mm long.There is buckling to the guidewire lumen 6.8cm, 7.5cm, and 27.5cm from the distal end of the returned device.The guidewire lumen is wavy between the 7.5cm and 27.5cm buckling.The exit notch is damaged and the tip is missing.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: 8166107
• MDR Text Key: 130391150
• Report Number: 2134265-2018-63922
• 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: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/18/2020
• Device Model Number: 7312
• Device Catalogue Number: 7312
• Device Lot Number: 0022816636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Initial Date Manufacturer Received: 11/26/2018
• Initial Date FDA Received: 12/14/2018
• Supplement Dates Manufacturer Received: 01/09/2019
• Supplement Dates FDA Received: 01/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other