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

Model Number 7213

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/14/2021

Event Type  Injury  

Event Description

It was reported that shaft break remained in the patient.The chronic totally occluded target lesion was located in anastomosis of left internal mammary artery to left anterior descending artery (lima/lad).A 2.00mm x15mm nc emerge balloon catheter was advanced for dilatation.However, during 2nd inflations the device fractured.The distal portion of the balloon was left in the patients body and some parts were able to be removed.Another wire was used to navigate the device fragments but it was unsuccessful and the procedure was cancelled or rescheduled.

Event Description

It was reported that shaft break remained in the patient.The chronic totally occluded target lesion was located in anastomosis of left internal mammary artery to left anterior descending artery (lima/lad).A 2.00mm x15mm nc emerge balloon catheter was advanced for dilatation.However, during 2nd inflations the device fractured.The distal portion of the balloon was left in the patients body and some parts were able to be removed.Another wire was used to navigate the device fragments but it was unsuccessful and the procedure was cancelled or rescheduled.It was further reported that the patient has been discharged and was being treated by medical management.There were no patient complications due to unretrieved device fragment.

Manufacturer Narrative

The returned product consisted of an nc emerge balloon catheter.The device was microscopically and visually examined.The hypotube of the device has numerous kinks.There was a separation of the shaft 119cm from the strain relief.The full length of the returned device including the hypotube extending past the midshaft bond is 124.2cm from the strain relief.There was contrast and blood in the inflation lumen.There was an 8mm exit notch tear as that was the point of separation at the most distal end of the remainder of the device.There was no guidewire lumen, balloon, or tip present upon device return.Product analysis confirmed the reported break as there was separation to the device.

Event Description

It was reported that shaft break remained in the patient.The chronic totally occluded target lesion was located in anastomosis of left internal mammary artery to left anterior descending artery (lima/lad).A 2.00mm x15mm nc emerge balloon catheter was advanced for dilatation.However, during 2nd inflations the device fractured.The distal portion of the balloon was left in the patients body and some parts were able to be removed.Another wire was used to navigate the device fragments but it was unsuccessful and the procedure was cancelled or rescheduled.It was further reported that the patient has been discharged and was being treated by medical management.There were no patient complications due to unretrieved device fragment.

• 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: 11880098
• MDR Text Key: 252728269
• Report Number: 2134265-2021-06788
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729846482
• UDI-Public: 08714729846482
• Combination Product (y/n): N
• PMA/PMN Number: K141236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/30/2021

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: 01/07/2023
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0026593562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Initial Date Manufacturer Received: 05/15/2021
• Initial Date FDA Received: 05/25/2021
• Supplement Dates Manufacturer Received: 05/27/2021; 06/18/2021
• Supplement Dates FDA Received: 06/18/2021; 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention