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

Model Number	H7493918908120
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed target lesion was located in the left anterior descending artery.A 1.20mm x 8mm emerge balloon catheter was advanced for dilation.However, it was noted that the middle of the balloon was fractured and the guidewire could not cross.The procedure was completed with another of same device.There were no patient complications reported.Patient was stable.
Additional Manufacturer Narrative
E1: initial reporter: (b)(6).
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed target lesion was located in the left anterior descending artery.A 1.20mm x 8mm emerge balloon catheter was advanced for dilation.However, it was noted that the middle of the balloon was fractured and the guidewire could not cross.The procedure was completed with another of same device.There were no patient complications reported.Patient was stable.
Additional Manufacturer Narrative
E1: initial reporter address and phone: (b)(6).Device evaluated by mfr: fg emerge mr, us 1.20mm x 8mm was returned for analysis.Visual or tactile inspection revealed multiple kinks were identified along the hypotube shaft.No issues or damages were found on the balloon profile.A detailed microscopic examination of the balloon material identified no issues.The inner lumen was pinched at the proximal balloon fold and just proximal of the bumper tip.Further analysis identified a stretched and bunched inner wire lumen, 6.9cm from tip of device.Bumper tip showed no signs of distal tip damage.A microscopic examination of the markerband identified no damages.The device could not be loaded or tracked guidewire due to the damage on the inner wire lumen.
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed target lesion was located in the left anterior descending artery.A 1.20mm x 8mm emerge balloon catheter was advanced for dilation.However, it was noted that the middle of the balloon was fractured and the guidewire could not cross.The procedure was completed with another of same device.There were no patient complications reported.Patient was 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: 20362022
• Report Number: 2124215-2024-61686
• Device Sequence Number: 8097093
• Product Code: LOX
• UDI-Device Identifier: 08714729806486
• UDI-Public: 08714729806486
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K130391
• 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
• Report Date (Section B): 01/28/2025

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 Expiration Date: 08/09/2026
• Device Model Number: H7493918908120
• Device Catalogue Number: H7493918908120
• Device Lot Number: 0033012933
• 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: 09/19/2024
• Supplement Date Received by Manufacturer: 11/24/2024; 01/14/2025
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 11/30/2024; 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2023
• 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: Female