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

Model Number	7212
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the balloon ruptured, and balloon material came off the tip and embolized in the distal artery.The target lesion was located in the moderately calcified distal right coronary artery (rca).A 4.00mm x 12mm nc emerge was selected for use.During the procedure, the balloon ruptured at 16 atmospheres and appeared to rupture circumferentially, and the tip seemed to come off and go down the rca.After several unsuccessful attempts to remove the device fragment, the patient was sent to coronary artery bypass (cabg) surgery.The device fragments remain in the rca.The patient was discharged in good condition post-surgery.
Additional Manufacturer Narrative
Correction to field a2: age at time of event from 57 to 58.
Event or Problem Description
It was reported that the balloon ruptured, and balloon material came off the tip and embolized in the distal artery.The target lesion was located in the moderately calcified distal right coronary artery (rca).A 4.00mm x 12mm nc emerge was selected for use.During the procedure, the balloon ruptured at 16 atmospheres and appeared to rupture circumferentially, and the tip seemed to come off and go down the rca.After several unsuccessful attempts to remove the device fragment, the patient was sent to coronary artery bypass (cabg) surgery.The device fragments remain in the rca.The patient was discharged in good condition post-surgery.It was further reported that this issue was reported via user facility maude#: mw5115465.
Additional Manufacturer Narrative
Correction to field a2: age at time of event from 57 to 58.Device evaluated by mfr: the complaint device was received for product analysis.The device was visually and microscopically examined.There were numerous hypotube kinks.There was blood and contrast in the inflation lumen and balloon.There was blood in the guidewire lumen, and the balloon was loosely folded.At approximately 9mm distal from the distal end of the proximal waist, there was full circumferential tear in the balloon.The guidewire lumen was stretched for a length of 2mm proximal to the separation.There was an incomplete device return as the tip, and the whole distal portion of the balloon failed to return.Product analysis was able to confirm the reported events as the balloon had a full circumferential tear and the tip and distal portion of the balloon was detached and failed to return for further analysis as it was reported left within the rca of the patient.
Event or Problem Description
It was reported that the balloon ruptured, and balloon material came off the tip and embolized in the distal artery.The target lesion was located in the moderately calcified distal right coronary artery (rca).A 4.00mm x 12mm nc emerge was selected for use.During the procedure, the balloon ruptured at 16 atmospheres and appeared to rupture circumferentially, and the tip seemed to come off and go down the rca.After several unsuccessful attempts to remove the device fragment, the patient was sent to coronary artery bypass (cabg) surgery.The device fragments remain in the rca.The patient was discharged in good condition post-surgery.It was further reported that this issue was reported via facility maude#: mw5115465.

• 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 SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16555077
• Report Number: 2124215-2023-12539
• Device Sequence Number: 11998847
• Product Code: LOX
• UDI-Device Identifier: 08714729846437
• UDI-Public: 08714729846437
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Followup
• Report Date (Section B): 05/26/2023

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: 10/17/2024
• Device Model Number: 7212
• Device Catalogue Number: 7212
• Device Lot Number: 0030364762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/23/2023
• Supplement Date Received by Manufacturer: 03/17/2023; 05/02/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 04/07/2023; 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2022
• 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: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Race: White