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

Model Number	7213
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Vascular Dissection (3160)
Date of Event	08/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture, balloon detach and unretrieved device fragment lead to additional surgery occurred.The target lesion was located in the very calcified diagonal branch.A 2.5x20 emerge balloon catheter was advanced and inflated at 10atmospheres (atm).A 2.5x26 non-boston scientific (bsc) stent was then placed in the lesion and post-dilated with a 2.5x15 nc emerge balloon catheter twice at 25 atm.The balloon was removed and they proceeded to treat the lesion with shockwave and a 2.5x15 wolverine cutting balloon.A 2.75x15 nc emerge balloon catheter was then advanced and inflated at 22 atm for 100 seconds.However, the balloon ruptured and when the balloon was deflated, they suspected a possible dissection.Upon removing the balloon they realized that part of the balloon was left in the patients body.Snaring the remains of the balloon was tried but unsuccessful.The patient was then taken to surgery for a triple bypass.No further patient complications were reported.
Additional Manufacturer Narrative
A2 age at time of event updated.A3 sex updated.A6 race updated.G2 report source updated.
Event or Problem Description
It was reported that balloon rupture, balloon detach and unretrieved device fragment lead to additional surgery occurred.The target lesion was located in the very calcified diagonal branch.A 2.5x20 emerge balloon catheter was advanced and inflated at 10atmospheres (atm).A 2.5x26 non-boston scientific (bsc) stent was then placed in the lesion and post-dilated with a 2.5x15 nc emerge balloon catheter twice at 25 atm.The balloon was removed and they proceeded to treat the lesion with shockwave and a 2.5x15 wolverine cutting balloon.A 2.75x15 nc emerge balloon catheter was then advanced and inflated at 22 atm for 100 seconds.However, the balloon ruptured and when the balloon was deflated, they suspected a possible dissection.Upon removing the balloon they realized that part of the balloon was left in the patients body.Snaring the remains of the balloon was tried but unsuccessful.The patient was then taken to surgery for a triple bypass.No further patient complications were reported.It was further reported that the detached part of the balloon was lodged in the left anterior descending artery.

• Brand Name: NC EMERGE
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 15217748
• Report Number: 2124215-2022-30040
• Device Sequence Number: 20513493
• Product Code: LOX
• UDI-Device Identifier: 08714729846512
• UDI-Public: 08714729846512
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2023

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: 11/30/2023
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0028468280
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2022
• Supplement Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 08/12/2022
• Supplement Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2021
• 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: Required Intervention; Other
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Race: White