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 Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the left anterior descending artery.A 3.5x12 nc emerge was advanced for dilatation.However, during the removal of the device, the balloon broke in half at the mid shaft.The physician advanced a second wire down and wrapped the distal shaft between the wires.The physician successfully removed the device from the patient's body.The procedure was completed with a non-bsc device.No patient complications were reported and the patient was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an nc emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was a complete separation at 46.3cm distal of the strain relief.There was contrast and blood in the inflation lumen, and blood in the guidewire lumen.The balloon was loosely folded.The device was soaked in a water bath for two days to loosen the blood and contrast in the device.An unknown guidewire was removed from the device.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the left anterior descending artery.A 3.5x12 nc emerge was advanced for dilatation.However, during the removal of the device, the balloon broke in half at the mid shaft.The physician advanced a second wire down and wrapped the distal shaft between the wires.He successfully removed the device in the patient's body.The procedure was completed with a non-bsc device.No patient complications were reported and the patient is fine.

• 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: 10985307
• Report Number: 2134265-2020-17274
• Device Sequence Number: 11588130
• Product Code: LOX
• UDI-Device Identifier: 08714729846413
• UDI-Public: 08714729846413
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/05/2022
• Device Model Number: 7212
• Device Catalogue Number: 7212
• Device Lot Number: 0026126857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 03/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention