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

Model Number	H7493918915150
Medical Device Problem Codes	Nonstandard Device (1420); Device-Device Incompatibility (2919); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4 - premarket: k163174.Device evaluated by mfr.: the device fg emerge mr, us 1.50mm x 15mm was returned for analysis.Visual, tactile, microscopic and wire insertion analysis was performed on the device.No issues were noted on the balloon profile.A kink was identified on the hypotube, 25.2cm distal to the distal end of the stain relief.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.Microscopic examination of the shaft identified a prolapsed and stretched inner wire lumen, 6.5cm from tip of device with a protruding outer lumen, 7cm from the tip.Tip showed no signs of tip damage.A microscopic examination of the proximal and distal markerbands identified no damage.The device could not be loaded or tracked on a test guidewire due to the damage on the inner wire lumen.No other device issues were identified during returned product analysis.
Event or Problem Description
Reportable based on device analysis completed on 26aug2025.It was reported that difficulty tracking over the wire were encountered.The target lesion was located in the coronary artery.The 1.50mm x 15mm emerge? balloon catheter was advanced.However, during insertion, the guidewire could not cross the port.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable post-procedure.However, returned device analysis revealed a tear on the outer lumen.
Event or Problem Description
Reportable based on device analysis completed on 26aug2025.It was reported that difficulty tracking over the wire were encountered.The target lesion was located in the coronary artery.The 1.50mm x 15mm emerge? balloon catheter was advanced.However, during insertion, the guidewire could not cross the port.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable post-procedure.However, returned device analysis revealed a tear on the outer lumen.
Additional Manufacturer Narrative
E1 - initial reporter email.G4 - premarket: k163174.Device evaluated by mfr.: the device fg emerge mr, us 1.50mm x 15mm was returned for analysis.Visual, tactile, microscopic and wire insertion analysis was performed on the device.No issues were noted on the balloon profile.A kink was identified on the hypotube, 25.2cm distal to the distal end of the stain relief.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.Microscopic examination of the shaft identified a prolapsed and stretched inner wire lumen, 6.5cm from tip of device with a protruding outer lumen, 7cm from the tip.Tip showed no signs of tip damage.A microscopic examination of the proximal and distal markerbands identified no damage.The device could not be loaded or tracked on a test guidewire due to the damage on the inner wire lumen.No other device issues were identified during returned product analysis.

• 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: 23113743
• Report Number: 2124215-2025-64579
• Device Sequence Number: 15920365
• Product Code: LOX
• UDI-Device Identifier: 08714729806189
• UDI-Public: (01)08714729806189(17)270303(10)34344414
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K121196
• 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): 12/11/2025

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: H7493918915150
• Device Catalogue Number: H7493918915150
• Device Lot Number: 0034344414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 09/22/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• 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 Age: 71 YR
• Patient Sex: Female
• Patient Weight: 66 KG