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

Model Number	7212
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Codes	Chest Pain (1776); Non specific EKG/ECG Changes (1817); Ischemia (1942)
Date of Event	06/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon would not deflate.The stenosed target lesion was located in the mid to proximal left anterior descending artery (lad).A 4.00mm x 12mm nc emerge balloon catheter was advanced for dilation.However, complications occurred when the balloon did not maintain the intended inflation pressure of 12 atmospheres, deflating to 10 atmospheres instead.Despite attempts to deflate the balloon over 30 to 90 seconds, it remained overinflated, leading to the procedure's termination.The balloon's removal was challenging, necessitating an unconventional method.The physician decided to puncture the balloon with a needle outside the patient's body to aid its release from the sheath and ensure its removal.Unfortunately, the patient developed ischemic symptoms, including st elevation and chest pain, during this process, which led to the immediate cessation of the procedure.After the balloon and related equipment were removed, the patient's condition stabilized.Despite encountering procedural difficulties, timely intervention prevented further complications, ensuring patient safety following the incident.No further complications reported.
Additional Manufacturer Narrative
The device was returned for analysis.A visual and tactile examination of the hypotube shaft profile identified no kinks or damages.A visual/tactile and microscopic examination of the distal extrusion identified that the extrusion was severely stretched down at approximately 2.3cm proximal from the proximal balloon sleeve.There were multiple kinks and evidence of stretching along the length of the extrusion.The inner was kinked just distal to the distal markerband.A microscopic examination of the balloon identified a pinhole in the balloon material, approximately 2mm proximal from the distal markerband.Functional testing was unable to be performed due to the damage in the inner/wire lumen, it was not possible to pass a 0.014inch size guidewire through the lumen.All attempts to inflate the balloon failed.The failure to inflate was due to the stretching and kinking that was evident along the distal extrusion.
Event or Problem Description
It was reported that the balloon would not deflate.The stenosed target lesion was located in the mid to proximal left anterior descending artery (lad).A 4.00mm x 12mm nc emerge balloon catheter was advanced for dilation.However, complications occurred when the balloon did not maintain the intended inflation pressure of 12 atmospheres, deflating to 10 atmospheres instead.Despite attempts to deflate the balloon over 30 to 90 seconds, it remained overinflated, leading to the procedure's termination.The balloon's removal was challenging, necessitating an unconventional method.The physician decided to puncture the balloon with a needle outside the patient's body to aid its release from the sheath and ensure its removal.Unfortunately, the patient developed ischemic symptoms, including st elevation and chest pain, during this process, which led to the immediate cessation of the procedure.After the balloon and related equipment were removed, the patient's condition stabilized.Despite encountering procedural difficulties, timely intervention prevented further complications, ensuring patient safety following the incident.No further complications reported.

• 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; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19633574
• Report Number: 2124215-2024-39073
• Device Sequence Number: 15606032
• Product Code: LOX
• UDI-Device Identifier: 08714729846437
• UDI-Public: 08714729846437
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/21/2026
• Device Model Number: 7212
• Device Catalogue Number: 7212
• Device Lot Number: 0033255407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2024
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2024
• 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
• Patient Sex: Unknown