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

Model Number	7213
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/14/2021
Type of Reportable Event	Serious Injury
Event or Problem 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11880098
• Report Number: 2134265-2021-06788
• Device Sequence Number: 11690014
• Product Code: LOX
• UDI-Device Identifier: 08714729846482
• UDI-Public: 08714729846482
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K141236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 05/15/2021
• Supplement Date Received by Manufacturer: 05/27/2021; 06/18/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 06/18/2021; 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention