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

Model Number	7214
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break occurred.The 80% stenosed target lesion was located in mildly tortuous and mildly calcified left anterior descending artery.A 3.50mm x 20mm nc emerge balloon catheter was advanced for dilatation.However, during removal, the shaft broke off at 24cm from the distal end.The detached portion of the device was attempted to be snared but was unsuccessful.The patient had to undergo an open heart surgery to completely remove the device fragment.No further complications were reported and the patient was fully recovered and discharged.
Event or Problem Description
It was reported that shaft break occurred.The 80% stenosed target lesion was located in mildly tortuous and mildly calcified left anterior descending artery.A 3.50mm x 20mm nc emerge balloon catheter was advanced for dilatation.However, during removal, the shaft broke off at 24cm from the distal end.The detached portion of the device was attempted to be snared but was unsuccessful.The patient had to undergo an open heart surgery to completely remove the device fragment.No further complications were reported and the patient was fully recovered and discharged.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an nc emerge balloon catheter.The device was microscopically and visually examined.There were numerous hypotube kinks to the device.There was contrast and blood in the inflation lumen and the balloon.The inflation lumen was stretched down from the midshaft bond for a length of 32.7cm and the was separated from the distal portion of the device.The total length of the distal portion of the device was 25cm and included the inflation lumen, guidewire lumen, balloon, and tip.The rapid port exchange was torn and at 6.2cm from the separation point there was a shaft kink.The balloon was loosely folded, and the tip of the device was damaged.R&d as well as da for engineering was contacted for verification of analysis and confirmed the device was separated and noted all the damages present that were not reported in the complaint event.Product analysis confirmed the reported events as there was separation to the device which would lead to difficulty removing the device.The device also had unreported kinks, stretched down inflation lumen, rapid port exchange tear, and tip damage 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12882199
• Report Number: 2134265-2021-14847
• Device Sequence Number: 14653289
• Product Code: LOX
• UDI-Device Identifier: 08714729846673
• UDI-Public: 08714729846673
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2022

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: 07/09/2023
• Device Model Number: 7214
• Device Catalogue Number: 7214
• Device Lot Number: 0027635003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2021
• Supplement Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 11/29/2021
• Supplement Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown