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

Model Number	7212
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	04/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that vessel perforation, shaft break and removal difficulty occurred requiring additional intervention.The target lesion was located in the moderately calcified left anterior descending artery (lad).After treatment with rotational atherectomy and shockwave therapy to address the calcification, a stent was implanted in the lad.A 4.50mm x 12mm nc emerge balloon catheter was then selected for post dilation of the stent.During post dilation, the vessel was perforated.The patient condition declined, and cardiopulmonary resuscitation (cpr) was initiated.Upon removal of the deflated emerge balloon, the balloon catheter broke into two pieces and part of the shaft remained in the patient's left main artery.After multiple attempts with a snare, the balloon shaft was successfully removed.Cpr was continued during the procedure and coils were placed to treat the perforation.The patient was intubated and at the time of reporting was in the intensive care unit (icu).

• 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: 19197165
• Report Number: 2124215-2024-25283
• Device Sequence Number: 12835750
• Product Code: LOX
• UDI-Device Identifier: 08714729846444
• UDI-Public: 08714729846444
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 04/26/2024

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: 11/28/2025
• Device Model Number: 7212
• Device Catalogue Number: 7212
• Device Lot Number: 0032954787
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2024
• Initial Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2023
• 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; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Race: White