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

Model Number	7214
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 2.75mm x 20mm nc emerge balloon catheter was used for dilation.However, it was noted that the distal portion of the balloon catheter broke off from the proximal portion.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an nc emerge balloon catheter.The device was microscopically and visually examined.The hypotube of the device has numerous kinks.There was a separation of the inflation lumen at 12.7cm distal to the midshaft bond (at the proximal end of the rapid port exchange).There was contrast in the inflation lumen on the proximal section of the separation.In the distal portion of the separation, there was contrast and blood in the inflation lumen and balloon.The rapid port exchange was torn.There was blood in the guidewire lumen and the balloon was loosely folded.No further damage was detected.There is no indication that the reported complaint is related to the manufacturing process.Product analysis confirmed the reported break as there was separation to the device.The device also had unreported numerous kinks, and the rapid port exchange was torn.
Event or Problem Description
It was reported that shaft break occurred.A 2.75mm x 20mm nc emerge balloon catheter was used for dilation.However, it was noted that the distal portion of the balloon catheter broke off from the proximal portion.There were no patient complications reported.

• Brand Name: NC EMERGE
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15116810
• Report Number: 2124215-2022-25157
• Device Sequence Number: 17559474
• Product Code: LOX
• UDI-Device Identifier: 08714729846642
• UDI-Public: 08714729846642
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2022

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: 02/07/2024
• Device Model Number: 7214
• Device Catalogue Number: 7214
• Device Lot Number: 0028819469
• 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: 06/30/2022
• Supplement Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 07/27/2022
• Supplement Report FDA Received Date: 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2022
• 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