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

Model Number	H7493919108200
Medical Device Problem Codes	Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: fg emerge otw, us 2.00mm x 8mm, catheter was returned to the complaint investigation site (cis).A visual and tactile inspection was performed and no issues identified with the hypotube shaft.No issues identified with the outer or mid-shaft sections or the inner lumen of the device.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.A microscopic examination of the markerbands identified that the distal markerband was compressed.Bumper tip detached and not returned.No other device issues were identified during returned product analysis.E1 initial reporter phone: (b)(6).Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
Reportable based on device analysis completed on (b)(6)2025.It was reported that crossing difficulties occurred.The 90% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending artery.A 2.00mm x 8mm emerge? balloon catheter was advanced for dilation, but the balloon could not cross the lesion.The procedure was completed with another of the same device.No patient complications were reported, and the patient was stable post procedure.However, returned device analysis revealed tip detachment.

• 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; two scimed place; maple grove MN 55311
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 23457476
• Report Number: 2124215-2025-78203
• Device Sequence Number: 8960831
• Product Code: LOX
• UDI-Device Identifier: 08714729807117
• UDI-Public: (01)08714729807117(17)270204(10)35778008
• 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
• Report Date (Section B): 11/03/2025

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: H7493919108200
• Device Catalogue Number: H7493919108200
• Device Lot Number: 0035778008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2025
• 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 Age: 77 YR
• Patient Sex: Male
• Patient Weight: 81 KG