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

Model Number	7213
Medical Device Problem Codes	Break (1069); Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation by mfr.: returned product consisted of the nc emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks in the hypotube and guidewire lumen.There was a complete separation of hypotube at 67.2cm distal of the strain relief.There was blood in the guidewire lumen.The balloon was tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
Reportable based on device analysis completed on 29-mar-2021.It was reported that shaft break occurred.A 6fr system was placed in the patient with two 0.14 wires and another balloon catheter were crossed the lesion.A 2.50mm x 15mm nc emerge balloon catheter was used for dilatation.However, the balloon catheter snapped off when the physician was attempting to insert the it over a 0.14 wire.The device was retrieved afterwards with no issues.There were no patient complications and a new balloon used thereafter was uneventful.It was further reported that there was some resistance during insertion of the 2.50mm x 15mm nc emerge balloon catheter.The break occurred 3-4 inches from the hub.The device only went inside the guide catheter, it was then taken out and off the wire by hand before it went into the body.However, returned device analysis revealed hypotube separation of 67.2cm distal of the strain relief.

• 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: 11675255
• Report Number: 2134265-2021-04467
• Device Sequence Number: 14345234
• Product Code: LOX
• UDI-Device Identifier: 08714729846505
• UDI-Public: 08714729846505
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 04/15/2021

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: 08/27/2022
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0025924561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 04/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1