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

Model Number	H7493919108150
Medical Device Problem Codes	Inflation Problem (1310); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).E1: initial reporter phone: (b)(6).Device evaluated by mfr.: the device was returned for analysis.Visual and tactile inspection found no issues with the hypotube shaft.No kinks or damages noted with the shaft polymer extrusion.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.Microscopic examination of the shaft identified that the inner wire lumen was stretched within the balloon and a pinhole was identified in the shaft underneath the markerband.The tip showed no signs of tip damage.A microscopic examination of the markerband identified that the markerband was compressed.The device was attached to an encore inflation unit and when an attempt was made to inflate the balloon to its rated burst pressure, a liquid leak was identified out through the tip of the device.The leak is consistent with the pinhole identified in the inner lumen in the shaft underneath the markerband.No other device issues were identified during returned product analysis.
Event or Problem Description
Reportable based on device analysis completed on 19-dec-2024.It was reported that inflation failure was encountered.A 1.50mm x 8mm emerge balloon catheter was used during the marshall procedure for atrial fibrillation.However, the balloon could not be opened.The procedure was completed with a different device and no patient complications were reported.However, returned device analysis revealed a pinhole in the shaft.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21133769
• Report Number: 2124215-2024-82846
• Device Sequence Number: 15332689
• Product Code: LOX
• UDI-Device Identifier: 08714729807100
• UDI-Public: 08714729807100
• 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
• Report Date (Section B): 01/10/2025

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: 06/10/2026
• Device Model Number: H7493919108150
• Device Catalogue Number: H7493919108150
• Device Lot Number: 0034204907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 01/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2024
• 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 Sex: Unknown