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

Model Number	7130
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	06/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 2.00mm x 8mm emerge balloon catheter was advanced for dilation.However, as the physician tried to inflate the device, the shaft broke.There were no patient complications reported.
Additional Manufacturer Narrative
D4: lot number updated.
Event or Problem Description
It was reported that shaft break occurred.A 2.00mm x 8mm emerge balloon catheter was advanced for dilation.However, as the physician tried to inflate the device, the shaft broke.There were no patient complications reported.
Event or Problem Description
It was reported that shaft break occurred.A 2.00mm x 8mm emerge balloon catheter was advanced for dilation.However, as the time they were going to inflate the device, the shaft broke.
Additional Manufacturer Narrative
Device evaluated by mfr.: fg emerge mr, us 2.00mm x 8mm was returned for analysis.A visual and tactile examination of the hypotube shaft identified multiple hypotube kinks and a break at 95.3cm distal to the distal end of the strain relief.A visual examination of the balloon identified no damages.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.A microscopic examination of the proximal and distal markerbands identified no damage.Bumper tip showed no signs of distal tip damage.

• 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: 19576354
• Report Number: 2124215-2024-37302
• Device Sequence Number: 20955744
• Product Code: LOX
• UDI-Device Identifier: 08714729806509
• UDI-Public: 08714729806509
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/20/2024

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: 09/19/2026
• Device Model Number: 7130
• Device Catalogue Number: 7130
• Device Lot Number: 0033239638
• 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: 06/07/2024
• Supplement Date Received by Manufacturer: 07/09/2024; 08/13/2024
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 07/09/2024; 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2024
• 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 Age: 82 YR
• Patient Sex: Unknown