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

Model Number	7141
Medical Device Problem Codes	Entrapment of Device (1212); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter phone: (b)(6).
Event or Problem Description
It was reported that catheter entrapment occurred.The target lesion was located in the left circumflex artery.A 2.00mm x 8mm emerge balloon catheter was selected for dilatation.Upon removal of the balloon catheter, the central cavity of the balloon could not be crossed after pressure dilation.Tip damaged was noted on the image data provided.The balloon catheter and guidewire were removed as one unit.The procedure was successfully completed using another of the same device.There were no reported patient complications, and their condition was stable post procedure.
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).The device was returned for analysis, a visual inspection revealed that at 3mm, and 2mm distal from the proximal markerband, and 3mm proximal from the tip of the device, the guidewire lumen was kinked.A microscopic inspection revealed no further damage or irregularity.There was contrast present in the inflation lumen and the loosely folded balloon, and there was blood in the guidewire lumen.The wire insertion of the guidewire used in the procedure was not returned for analysis, so a test 0.014 guidewire was used for functional testing.The test guidewire was unable to pass through the balloon portion of the device due to the kink nearest the tip.A media image was provided and depicts a full view of the balloon catheter.Kink damage is noted to be within the balloon which aligns to what is seen in device analysis.
Event or Problem Description
It was reported that catheter entrapment occurred.The target lesion was located in the left circumflex artery.A 2.00mm x 8mm emerge balloon catheter was selected for dilatation.Upon removal of the balloon catheter, the central cavity of the balloon could not be crossed after pressure dilation.Tip damaged was noted on the image data provided.The balloon catheter and guidewire were removed as one unit.The procedure was successfully completed using another of the same device.There were no reported patient complications, and their condition was stable post procedure.

• 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: 19102218
• Report Number: 2124215-2024-21954
• Device Sequence Number: 15379782
• Product Code: LOX
• UDI-Device Identifier: 08714729807117
• UDI-Public: 08714729807117
• 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
• Report Date (Section B): 06/10/2024

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: 03/07/2025
• Device Model Number: 7141
• Device Catalogue Number: 7141
• Device Lot Number: 0031193692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2024
• Supplement Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2023
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Weight: 80 KG