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

Model Number	7212
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a shaft break occurred.The 80% stenosed target lesion was located in the mildly calcified and moderately tortuous coronary artery.A 3.50mm x 12mm emerge balloon catheter kinked as it was being inserted.As the device was being removed it broke in two pieces.The emerge catheter was not fully inserted into the patient so the broken catheter was removed with the physician hand.The procedure was completed with another same device.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 device has numerous kinks.There was a hypotube separation 80cm from the strain relief.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded, and there was blood present in the folds.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported break and kinks as there was separation to the device as well as numerous kinks.
Event or Problem Description
It was reported that a shaft break occurred.The 80% stenosed target lesion was located in the mildly calcified and moderately tortuous coronary artery.A 3.50mm x 12mm emerge balloon catheter kinked as it was being inserted.As the device was being removed it broke in two pieces.The emerge catheter was not fully inserted into the patient so the broken catheter was removed with the physician hand.The procedure was completed with another same device.No patient complications were 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
• MDR Report Key: 12168190
• Report Number: 2134265-2021-08991
• Device Sequence Number: 3988874
• Product Code: LOX
• UDI-Device Identifier: 08714729846413
• UDI-Public: 08714729846413
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 08/12/2021

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: 10/19/2022
• Device Model Number: 7212
• Device Catalogue Number: 7212
• Device Lot Number: 0026206788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 08/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR