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

Model Number 7314

Device Problem Deflation Problem (1149)

Patient Problem Ischemia (1942)

Event Date 05/04/2019

Event Type  Injury  

Event Description

It was reported that failure to deflate a balloon and ischemia occurred.The target lesion was located in the left anterior descending artery (lad).After implantation of a stent, a 2.50mm x 20mm nc emerge balloon was placed through the stent meshes in the first diagonal (d1), expanded with 14 bar.There was good expansion, but was hard to deflate.With some effort, it was possible to deflate the balloon and remove it from the vessel.A guiding catheter was advanced in the proximal lad and the balloon was forced inside.It was very difficult to retreat in the guiding catheter, but was then suddenly possible to retreat the balloon which was presumed to be the result of destruction to the shaft and the balloon deflation.The patient had experienced temporary ischemia.The procedure was completed without any additional patient complications and the patient status was good after further preparation and stenting.

Event Description

It was reported that failure to deflate a balloon and ischemia occurred.The target lesion was located in the left anterior descending artery (lad).After implantation of a stent, a 2.50mm x 20mm nc emerge balloon was placed through the stent meshes in the first diagonal (d1), expanded with 14 bar.There was good expansion, but was hard to deflate.With some effort, it was possible to deflate the balloon and remove it from the vessel.A guiding catheter was advanced in the proximal lad and the balloon was forced inside.It was very difficult to retreat in the guiding catheter, but was then suddenly possible to retreat the balloon which was presumed to be the result of destruction to the shaft and the balloon deflation.The patient had experienced temporary ischemia.The procedure was completed without any additional patient complications and the patient status was good after further preparation and stenting.

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 on the hypotube.The shaft was stretched from the midshaft bond to the exit notch.There was contrast and blood in the inflation lumen and balloon.The balloon was loosely folded.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there would have been difficulty deflating the balloon due to the stretched down shaft.

• 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: 8664759
• MDR Text Key: 146895637
• Report Number: 2134265-2019-05673
• 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: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2021
• Device Model Number: 7314
• Device Catalogue Number: 7314
• Device Lot Number: 0023429170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• Date Manufacturer Received: 06/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention