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

Model Number	7213
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an nc emerge balloon catheter.A visual inspection revealed that at 42.8cm from the strain relief, the hypotube was separated.There were numerous hypotube kinks to the device.A microscopic inspection revealed no damage or irregularity.There was contrast and blood in the inflation lumen, and the balloon was tightly folded.A media depicts a portion of the device showing a separation and kink to the hypotube.There was an additional photo showing the tyvek packaging to the reported complaint batch.The damage shown in the media confirmed the reported break.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the moderately tortuous and severely calcified coronary artery.A 2.25mm x 15mm nc emerge balloon catheter was advanced for dilation.However, upon removing the balloon from the guide, the midshaft of the balloon broke in half.The detached portion of the device was pulled out of the non-boston scientific guide catheter and body, and the device was removed intact from the patient.The procedure was completed with a different device.No patient complications were reported.

• 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; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19269785
• Report Number: 2124215-2024-27858
• Device Sequence Number: 6981185
• Product Code: LOX
• UDI-Device Identifier: 08714729846499
• UDI-Public: 08714729846499
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/08/2024

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: 06/25/2025
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0031891085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2023
• 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 Sex: Unknown