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

Model Number	7214
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 date of event: used the first day of the month of the bsc aware date since no event date was provided.Device evaluated by mfr: the fg nc emerge mr, us 4.00mm x 20mm balloon catheter was returned for analysis.Visual, tactile and microscopic analysis as well as functional testing was performed on the device.No issues identified with the shaft.A visual inspection of the outer and inner lumen and tactile examination of the entire extrusion found no issues.A detailed microscopic examination of the balloon identified pinhole leaks 7mm and 9mm distal to the proximal markerband.Bumper tip showed no signs of distal tip damage.There were traces of blood noted inside the balloon.The device was attached to an encore inflation unit and the balloon was observed to have pinhole leaks at two locations.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2024.A 4.00mm x 20mm nc emerge balloon catheter was reported with no alleged device issue.However, investigation result revealed a balloon pinhole.

• Brand Name: NC 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: 20737803
• Report Number: 2124215-2024-73194
• Device Sequence Number: 20927031
• Product Code: LOX
• UDI-Device Identifier: 08714729846697
• UDI-Public: 08714729846697
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K141236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/20/2024

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: 04/23/2026
• Device Model Number: 7214
• Device Catalogue Number: 7214
• Device Lot Number: 0033880958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2024
• 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