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

Model Number	H7493918920200
Medical Device Problem Codes	Break (1069); Inflation Problem (1310); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).G4: premarket / 510(k) #k163174.Good faith effort attempts were made to try and retrieve the device status, but it was unable to be obtained.
Event or Problem Description
It was reported that a shaft break occurred.The 75% stenosed target lesion was located in the mildly tortuous and mildly calcified left anterior descending artery.A 2.00mm x 20mm emerge balloon catheter was advanced for dilatation.During the procedure, the device was delivered to the target site but failed to inflate.Upon withdrawal, the shaft broke.The procedure was completed with another of same device.No complications were reported, and the patient remained stable throughout the procedure.
Additional Manufacturer Narrative
(b)(6).G4: premarket / 510(k) #k163174.The device was returned for analysis.A visual and tactile examination of the hypotube shaft identified a break located 41 cm distal to the distal end of the strain relief.Additionally, multiple kinks were observed along the hypotube.Examination of the inner lumen and midshaft sections revealed no issues.Microscopic analysis of the balloon cones showed no defects, and no pinholes or tears were identified in the balloon.The bumper tip was intact, with no signs of damage.A functional test was conducted despite the hypotube break.The device was connected to an inflation aid, and the balloon was inflated without issue to its rated burst pressure (rbp) of 14 atmospheres.The balloon fully inflated and maintained pressure for 15 seconds with no leaks observed.A vacuum was applied, and the balloon deflated completely without resistance.This inflation and deflation cycle was repeated three additional times, with no issues noted.No other device issues were identified during the returned product analysis.
Event or Problem Description
It was reported that a shaft break occurred.The 75% stenosed target lesion was located in the mildly tortuous and mildly calcified left anterior descending artery.A 2.00mm x 20mm emerge balloon catheter was advanced for dilatation.During the procedure, the device was delivered to the target site but failed to inflate.Upon withdrawal, the shaft broke.The procedure was completed with another of same device.No complications were reported, and the patient remained stable throughout the procedure.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 21841062
• Report Number: 2124215-2025-23359
• Device Sequence Number: 7851925
• Product Code: LOX
• UDI-Device Identifier: 08714729806301
• UDI-Public: (01)08714729806301(17)270423(10)34680806
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2025

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: H7493918920200
• Device Catalogue Number: H7493918920200
• Device Lot Number: 0034680806
• 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: 03/27/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 04/15/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2024
• 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