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

Model Number	7212
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 2.50mm x 12mm nc emerge balloon catheter was selected for use.However, during unpacking, it was noted that the shaft was fractured within 30 centimeters from the hub.The procedure was completed with another same device.
Event or Problem Description
It was reported that shaft break occurred.A 2.50mm x 12mm nc emerge balloon catheter was selected for use.However, during unpacking, it was noted that the shaft was fractured within 30 centimeters from the hub.The procedure was completed with another same device.
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 3 kinks total; 50.2cm, and 60.2cm from the strain relief and the one kink 76.6cm from tip of the device.There was a separation 65.3cm from the strain relief.The balloon was tightly folded, and contrast present in the folds.Inspection of the remainder of the device presented no other damage or irregularities.The device also had numerous kinks to the device.

• 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: 11659968
• Report Number: 2134265-2021-04312
• Device Sequence Number: 4225141
• Product Code: LOX
• UDI-Device Identifier: 08714729846376
• UDI-Public: 08714729846376
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2021

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: 11/13/2022
• Device Model Number: 7212
• Device Catalogue Number: 7212
• Device Lot Number: 0026355896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 68