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

Model Number 7313

Device Problem Break (1069)

Patient Problems Perforation of Vessels (2135); No Code Available (3191)

Event Date 03/24/2020

Event Type  Injury  

Event Description

It was reported that shaft break and vessel perforation occurred.The target lesion was located in the mid left anterior descending artery.Following predilitation with 2.0 x12mm, 2.25 x 15mm, 2.5x 15mm, and 1.5 x 12mm emerge balloons and a 2.5 x 10mm wolverine cutting balloon, a 2.5x38mm synergy stent was placed.A 2.50mm x 15mm nc emerge balloon catheter was advanced for post-dilation but upon inflation up to 30 atmospheres, a perforation at the proximal lad was noted.When the nc emerge balloon was removed it was noted that the shaft was broken.The perforation was treated by implanting a 3.0x38mm synergy stent.There were no further patient complications reported and the patient's status was stable.

Event Description

It was reported that shaft break and vessel perforation occurred.The target lesion was located in the mid left anterior descending artery.Following predilatation with 2.0 x12mm, 2.25 x 15mm, 2.5x 15mm, and 1.5 x 12mm emerge balloons and a 2.5 x 10mm wolverine cutting balloon, a 2.5x38mm synergy stent was placed.A 2.50mm x 15mm nc emerge balloon catheter was advanced for post-dilation but upon inflation up to 30 atmospheres, a perforation at the proximal lad was noted.When the nc emerge balloon was removed it was noted that the shaft was broken.The perforation was treated by implanting a 3.0x38mm synergy stent.There were no further patient complications reported and the patient's status was stable.

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 contrast in the inflation lumen and balloon.The balloon was loosely folded.There was a tear on the shaft 5mm long starting 27mm from the tip.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: 9922377
• MDR Text Key: 186699180
• Report Number: 2134265-2020-04365
• 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: 06/09/2020

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: 11/05/2021
• Device Model Number: 7313
• Device Catalogue Number: 7313
• Device Lot Number: 0024720292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2020
• Initial Date Manufacturer Received: 03/30/2020
• Initial Date FDA Received: 04/03/2020
• Supplement Dates Manufacturer Received: 05/14/2020
• Supplement Dates FDA Received: 06/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention