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

Model Number	7133
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Chest Pain (1776); Perforation (2001); Restenosis (4576)
Date of Event	02/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that perforation and chest pain occurred.The stenosed target lesion was located in the middle right coronary artery (rca).A 2.00mm x 15mm fg emerge balloon catheter was advanced for dilation.However, during multiple inflation of the device it resulted in a small perforation in the right coronary artery (rca).The balloon was left reinflated for 10 minutes, then a non-boston scientific device was used to cover the stent and was quickly advanced and inflated.Following stent deployment, a synergy xd stent was placed in the proximal right coronary artery (rca) and post-dilated.The procedure was completed with a different device.The patient experiences some chest pain but never hemodynamically unstable because of the perforation of rotablator atherectomy and balloon dilatation of right coronary artery (rca), post-procedure the patient status was hemodynamically stable.

• Brand Name: 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: 18788487
• Report Number: 2124215-2024-11440
• Device Sequence Number: 8351747
• Product Code: LOX
• UDI-Device Identifier: 08714729806196
• UDI-Public: 08714729806196
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: K113220
• 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): 02/27/2024

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 Model Number: 7133
• Device Catalogue Number: 7133
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Female