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 Codes	Foreign Body In Patient (2687); Vascular Dissection (3160); Foreign Body Embolism (4439)
Date of Event	05/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via facility medwatch report (b)(4) that shaft break, vessel dissection, and embolism occurred.A heart catheterization was performed in work up for a transcatheter aortic valve replacement (tavr).A 3.00mm x 15mm nc emerge balloon catheter was advanced for dilation.However, when the balloon was backed out, the shaft of the balloon broke off "after the black tip, proximal part of the monorail" causing coronary artery dissection and embolization.Dissection was at 100% non-flowing and there was no snaring involved.The physician decided to leave the balloon in the vessel because the vessel was poor.The patient was monitored for 1.5 hours post procedure in the catheterization lab and then was moved to critical care for monitoring and overnight observation.An echocardiogram was performed to evaluate for left ejection friction and regional wall motion, no changes were noted.The patient was discharged the following day and will be anticipating tavr done in 1 month.
Additional Manufacturer Narrative
E1: initial reporter title: risk manager.Device evaluated by mfr.: the complaint device was not received at the complaint investigation site for analysis.Photo media was provided for investigation review.Photos one and two show the end of a device, a batch number cannot be determined as the photo did not provide evidence of the lot number.No damage was depicted to the photo and is deemed not applicable.The photo tree shows one part and the end of a device, a batch number cannot be determined as the photo did not provide evidence of the lot number.No damage was depicted to the photo and is deemed not applicable.Photo four depicts a device that contains blood on the manifold and looks to be separated at the end of the shaft from the balloon.There also shows the lot number on the manifold 28906590 which matches the complaint batch, and therefore applies to this compliant.Photo five shows one part and the end of a device, a batch number cannot be determined as the photo did not provide evidence of the lot number.No damage was depicted to the photo and is deemed not applicable.
Event or Problem Description
It was reported via facility medwatch report (b)(4) that shaft break, vessel dissection, and embolism occurred.A heart catheterization was performed in work up for a transcatheter aortic valve replacement (tavr).A 3.00mm x 15mm nc emerge balloon catheter was advanced for dilation.However, when the balloon was backed out, the shaft of the balloon broke off "after the black tip, proximal part of the monorail" causing coronary artery dissection and embolization.Dissection was at 100% non-flowing and there was no snaring involved.The physician decided to leave the balloon in the vessel because the vessel was poor.The patient was monitored for 1.5 hours post procedure in the catheterization lab and then was moved to critical care for monitoring and overnight observation.An echocardiogram was performed to evaluate for left ejection friction and regional wall motion, no changes were noted.The patient was discharged the following day and will be anticipating tavr done in 1 month.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14739238
• Report Number: 2134265-2022-06291
• Device Sequence Number: 6048288
• Product Code: LOX
• UDI-Device Identifier: 08714729846529
• UDI-Public: 08714729846529
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2022

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: 02/21/2024
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0028906590
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/27/2022
• Supplement Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Other; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 85 KG