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

Model Number	7211
Medical Device Problem Codes	Break (1069); Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture, balloon detachment, and shaft break occurred.The target lesion was located in the mildly tortuous and moderately calcified left anterior descending artery.A 3.50mm x 8mm nc emerge balloon catheter was advanced for dilation.However, the balloon ruptured after inflation and came off the rail system.It was also noted that the shaft fractured.The physician removed the balloon intact via a gooseneck snare.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that balloon rupture, balloon detachment, and shaft break occurred.The target lesion was located in the mildly tortuous and moderately calcified left anterior descending artery.A 3.50mm x 8mm nc emerge balloon catheter was advanced for dilation.However, the balloon ruptured after inflation and came off the rail system.It was also noted that the shaft fractured.The physician removed the balloon intact via a gooseneck snare.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an nc emerge balloon catheter.The device was visually and microscopically examined.There was blood present in the manifold.There were numerous severe kinks to the hypotube and shaft.There was blood and contrast in the inflation lumen.At 135cm from the strain relief, there was an inflation lumen separation.The edges were jagged and visibly bunched and accordioned indicating the lumen could have burst or damage occurred while device was removed.At 136cm-137.3cm from the strain relief the guidewire lumen was stretched down, and blood was present.At 137.3cm from the strain relief the guidewire lumen was separated.The separated ends were jagged indicating the device was torn.The total length of the distal portion of the separation is 5.7cm, which includes both markerbands, balloon and tip of the device.The balloon had contrast and blood present.The balloon was bunched, accordioned, and the distal portion of the balloon was prolapsed.The damage to the device was too severe to confirm if the balloon burst.The tip of the device was also damaged.The balloon and device damage were too severe to functionally test for a burst in the balloon.The balloon was also still attached to the shaft and tip of the device indicating detachment of the balloon did not occur.

• 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: 12625017
• Report Number: 2134265-2021-12556
• Device Sequence Number: 11119744
• Product Code: LOX
• UDI-Device Identifier: 08714729846284
• UDI-Public: 08714729846284
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 12/08/2021

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: 08/09/2023
• Device Model Number: 7211
• Device Catalogue Number: 7211
• Device Lot Number: 0027800981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/29/2021
• Supplement Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2021
• 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: Required Intervention
• Patient Sex: Unknown