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

Model Number	H7493918915200
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a frozen guidewire occurred.The 75% stenosed target lesion was located in the mildly tortuous and mildly calcified left coronary artery.A 2.00mm x 15mm emerge balloon catheter was advanced for dilatation.However, during withdrawal, the guidewire became stuck.The procedure was completed with another of same device.No patient complications were reported, and the patient remained stable.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).E1: initial reporter phone: (b)(6) g4: premarket / 510(k): k163174.
Event or Problem Description
It was reported that a frozen guidewire occurred.The 75% stenosed target lesion was located in the mildly tortuous and mildly calcified left coronary artery.A 2.00mm x 15mm emerge balloon catheter was advanced for dilatation.However, during withdrawal, the guidewire became stuck.The procedure was completed with another device of the same type.No patient complications were reported, and the patient remained stable.It was further reported that the device could not be removed normally due to resistance and was removed through various attempted methods.
Additional Manufacturer Narrative
H6: impact codes: updated impact codes.E1: initial reporter address 1: (b)(6).E1: initial reporter phone: (b)(6).G4: premarket / 510(k): k163174.
Additional Manufacturer Narrative
B1: updated adverse event/product problem.B2: updated outcomes attrib to adv event.B5: describe event or problem: updated to include new information obtained.H1: updated type of reportable event.H6: impact codes: updated impact codes.E1: initial reporter: (b)(6).G4: premarket / 510(k): k163174.
Event or Problem Description
It was reported that a frozen guidewire occurred.The 75% stenosed target lesion was located in the mildly tortuous and mildly calcified left coronary artery.A 2.00mm x 15mm emerge balloon catheter was advanced for dilatation.However, during withdrawal, the guidewire became stuck.The procedure was completed with another device of the same type.No patient complications were reported, and the patient remained stable.It was further reported that the device could not be removed normally due to resistance and was removed through various attempted methods.It was further reported that the device was simply removed as a whole.
Event or Problem Description
It was reported that a frozen guidewire occurred.The 75% stenosed target lesion was located in the mildly tortuous and mildly calcified left coronary artery.A 2.00mm x 15mm emerge balloon catheter was advanced for dilatation.However, during withdrawal, the guidewire became stuck.The procedure was completed with another device of the same type.No patient complications were reported, and the patient remained stable.It was further reported that the device could not be removed normally due to resistance and was removed through various attempted methods.It was further reported that the device was simply removed as a whole.
Additional Manufacturer Narrative
B1: updated adverse event/product problem b2: updated outcomes attrib to adv event b5: describe event or problem: updated to include new information obtained.H1: updated type of reportable event h6: impact codes: updated impact codes.E1: initial reporter address 1: (b)(6) g4: premarket / 510(k): k163174.Device evaluated by manufacturer: the device was returned for analysis.Visual, tactile, microscopic and wire insertion testing were performed on the device.Visual and tactile inspection of hypotube and shaft polymer extrusion found no issues.Balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A microscopic examination of the proximal and distal markerbands identified no damage.Bumper tip showed no signs of distal tip damage.The inner lumen was stretched at 4.6cm from the distal tip.The device could not be fully loaded and tracked over a 0.014'' guidewire due to inner lumen damage at 4.6cm from distal tip.No 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: 20834800
• Report Number: 2124215-2024-75613
• Device Sequence Number: 11802147
• Product Code: LOX
• UDI-Device Identifier: 08714729806196
• UDI-Public: 08714729806196
• 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,Followup,Followup
• Report Date (Section B): 02/12/2025

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 Model Number: H7493918915200
• Device Catalogue Number: H7493918915200
• Device Lot Number: 0034034167
• 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: 11/19/2024
• Supplement Date Received by Manufacturer: 12/01/2024; 12/23/2024; 01/22/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 12/17/2024; 01/16/2025; 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2024
• 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: 81 YR
• Patient Sex: Female
• Patient Weight: 50 KG