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

Model Number	H7493926708350
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via user medwatch (b)(4) that balloon rupture occurred requiring additional intervention.The in-stent restenosis lesions were located in the right coronary artery (rca).A 3.50mm x 8mm nc emerge balloon catheter was advanced for dilation.A prolonged high-pressure inflation was performed and the balloon ruptured.There was difficulty retrieving the balloon into the non-boston scientific (bsc) guide catheter.A guide extension was advanced over the balloon to remove the balloon, guidewire, and non-bsc guide catheter as one unit.However, this led to balloon avulsion off of the shaft of the balloon delivery system.The balloon fragment seen in the proximal rca stent segment.Snaring was attempted using a 2-wire twist technique with new guidewires but was unsuccessful.Subsequently, an attempt was made to suction the remaining fragment using a non-bsc device, but it was also unsuccessful.The physician then used a 1.5 x 12 mm non-bsc balloon catheter to pull it back into the guide, but this only moved a segment of the balloon from the proximal segment to the mid-segment, as could be seen by the balloon markers.Shortly after, the physician decided that the best option was to trap the balloon segments behind stent struts.Given that the patient had two layers of stents from the proximal to the distal rca and the balloon was only 8 mm in length, a 2.75 x 8 mm synergy drug-eluting stent (des) was deployed in the mid-segment, aligned with the balloon's biomarker.A second 2.75 x 8 mm synergy des was placed in the proximal stent segment, aligned with the first biomarker.The patient remained hemodynamically stable, telemetry did not show any st elevations, and the patient had timi 3 flow in both vessels.There was still a residual 20% area of under-expanded stent in the proximal segment distal to the second placed stent, but flow down the vessel remained timi 3, and the patient continued to be hemodynamically stable.No further issues were 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 ; MY 14110
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 21417333
• Report Number: 2124215-2025-08861
• Device Sequence Number: 9198700
• Product Code: LOX
• UDI-Device Identifier: 08714729846284
• UDI-Public: 08714729846284
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2025

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: 02/25/2026
• Device Model Number: H7493926708350
• Device Catalogue Number: H7493926708350
• Device Lot Number: 0033498453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 02/19/2025
• Date Device Manufactured: 02/26/2024
• 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 Age: 77 YR
• Patient Sex: Female
• Patient Weight: 74 KG