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

Model Number	7214
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	03/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a break had occurred.While the physician was advancing a 2.5 x 20 nc emerge balloon catheter into the guide catheter when the shaft separated into two pieces.The balloon was still in the guide and was able to be removed with no harm to the patient.A new balloon was opened and the case was completed successfully.
Event or Problem Description
It was reported that a break had occurred.While the physician was advancing a 2.5 x 20 nc emerge balloon catheter into the guide catheter when the shaft separated into two pieces.The balloon was still in the guide and was able to be removed with no harm to the patient.A new balloon was opened and the case was completed successfully.
Additional Manufacturer Narrative
Device evaluated by mfr: the 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 45.1cm from the strain relief.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded and had contrast and blood in the folds.

• 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
• MDR Report Key: 11686566
• Report Number: 2134265-2021-04996
• Device Sequence Number: 11545373
• Product Code: LOX
• UDI-Device Identifier: 08714729846635
• UDI-Public: 08714729846635
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2021

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: 01/22/2023
• Device Model Number: 7214
• Device Catalogue Number: 7214
• Device Lot Number: 0026675861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 05/20/2021
• Patient Sequence Number: 1