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

Model Number	H7493919108150
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) hospital.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
It was reported that balloon rupture occurred.The 92% stenosed target lesion was located in a severely tortuous and severely calcified right coronary artery.A 1.50mm x 8mm emerge? balloon catheter was advanced for dilatation.However, during the preparation, it was noted that the balloon was ruptured and leaking liquid.The procedure was completed with another of the same device without any patient complications reported.The patient status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The 92% stenosed target lesion was located in a severely tortuous and severely calcified right coronary artery.A 1.50mm x 8mm emerge? balloon catheter was advanced for dilatation.However, during the preparation, it was noted that the balloon was ruptured and leaking liquid.The procedure was completed with another of the same device without any patient complications reported.The patient status was stable.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (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.Investigation results: media review: a photo was returned with the complaint information, showing the hub/manifold of the emerge device.Returned media cannot confirm the reported allegation.Device analysis findings: the 1.50mm x 8mm fg emerge otw balloon catheter was returned for analysis.A visual and tactile examination showed no issues identified with the outer / mid-shaft sections or the inner lumen of the device.A detailed examination of the balloon material found no issues.Balloon wings were subjected to positive pressure and was returned in a deflated state.A microscopic examination of the markerband identified no damage and bumper tip showed no signs of distal tip damage.A leakage test was performed.The device was attached to an encore inflation device, and the balloon was inflated to rated burst pressure of 20 atmospheres with no issues.The encore device verified before and after use using the druck gauge.No other device issues were identified during returned product analysis.Device history record review: it was confirmed that this device met manufacturing specification prior to distribution and there no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a risk review was performed, and it confirmed that the event was defined in the risk documentation and is recorded accordingly in the product record review table.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: this product investigation is assigned the most probable cause classification of no problem detected.This code was selected as the most probable complaint cause based on the limited information available.It was reported that balloon ruptured.The reported event could not be confirmed as the balloon was inflated to rated burst pressure of 20 atmospheres with no leaks or issues.

• 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: 24304764
• Report Number: 2124215-2026-07404
• Device Sequence Number: 5142811
• Product Code: LOX
• UDI-Device Identifier: 08714729807100
• UDI-Public: (01)08714729807100(17)270319(10)36099383
• 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): 04/02/2026

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: H7493919108150
• Device Catalogue Number: H7493919108150
• Device Lot Number: 0036099383
• 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: 01/15/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2025
• 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: 88 YR
• Patient Sex: Female
• Patient Weight: 62 KG