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

Model Number	7213
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that catheter removal difficulties and a shaft break were encountered.The patient experiencing cardiovascular instability and persistent ischemic symptoms, including chest pains.An electrocardiogram (ekg) indicated a concern for an inferior st elevation myocardial infarction (stemi).A 5.50mm x 15mm nc emerge balloon catheter was advanced for dilatation.However, during intervention, there was difficulty withdrawing the balloon, which ultimately resulted in a balloon shaft fracture.The balloon tip and shaft remained just proximal to the guideliner.When pulled back into the guideliner, about 20cm of the balloon remained in the patient out the guide.The balloon shaft and tip were successfully retrieved.All equipment was removed intact, with no apparent harm to the patient.
Additional Manufacturer Narrative
B3: used (b)(6) 2024 as event date since the only date provided was (b)(6) 2024.
Additional Manufacturer Narrative
Updated: b1: adverse event/problem.B2: outcomes attrib to adv event.B5 - describe event or problem.H1: type of reportable event.H6: impact code.B3: used (b)(6) 2024 as event date since the only date provided was (b)(6) 2024.
Event or Problem Description
It was reported that catheter removal difficulties and a shaft break were encountered.The patient experiencing cardiovascular instability and persistent ischemic symptoms, including chest pains.An electrocardiogram (ekg) indicated a concern for an inferior st elevation myocardial infarction (stemi).A 5.50mm x 15mm nc emerge balloon catheter was advanced for dilatation.However, during intervention, there was difficulty withdrawing the balloon, which ultimately resulted in a balloon shaft fracture.The balloon tip and shaft remained just proximal to the guideliner.When pulled back into the guideliner, about 20cm of the balloon remained in the patient out the guide.The balloon shaft and tip were successfully retrieved.All equipment was removed intact, with no apparent harm to the patient.It was further reported that the target lesion was moderately tortuous with 70% stenosis and snaring was performed to completely removed the fractured device.

• 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 ; MY 14110
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20568310
• Report Number: 2124215-2024-66870
• Device Sequence Number: 7873060
• Product Code: LOX
• UDI-Device Identifier: 08714729846598
• UDI-Public: 08714729846598
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2024

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: 01/10/2026
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0033185335
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 11/18/2024
• Date Device Manufactured: 01/11/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male