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

Model Number	7211
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unintended Radiation Exposure (4565)
Date of Event	09/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that difficulty removal and shaft break occurred requiring an additional intervention.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified left main (lm) artery.A 6.00mm x 8mm nc emerge balloon catheter was advanced for post-dilatation.However, during withdrawal after deflation, the balloon was stuck in the lm implanted stent.When physician applied force to remove the balloon, the shaft was fractured at about 15cm from the distal tip.The balloon and the rest of the shaft left inside the patient's coronary artery.The fragment was snared out of the body successfully.This required a prolonged procedure with additional radiation and blood loss.The procedure was completed with a 12x6 nc balloon catheter and there were no patient complications reported.
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 and shaft kinks to the device.There was blood and contrast to the inflation lumen and the balloon.There was blood in the guidewire lumen, and the balloons were found to be loosely folded.The proximal portion of the inflation lumen (from midshaft bond to the rpe) was stretched and fully separated just distal to the rapid port exchange (rpe).The guidewire lumen was stretched from the rpe moving distal for a length of 3mm.There was twisting to the shaft and the balloon of the device.There was full detachment of the guidewire lumen within the shaft (inflation lumen) at the distal waist.There was visible texture noted to the distal portion of the balloon, and the tip of the device was damaged.Product analysis confirmed the reported separation and removal difficulties as the inflation lumen and guidewire lumen were separated and the stretched and twisted shaft damage to the device indicate procedural and removal difficulties.
Event or Problem Description
It was reported that difficulty removal and shaft break occurred requiring an additional intervention.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified left main (lm) artery.A 6.00mm x 8mm nc emerge balloon catheter was advanced for post-dilatation.However, during withdrawal after deflation, the balloon was stuck in the lm implanted stent.When physician applied force to remove the balloon, the shaft was fractured at about 15cm from the distal tip.The balloon and the rest of the shaft left inside the patient's coronary artery.The fragment was snared out of the body successfully.This required a prolonged procedure with additional radiation and blood loss.The procedure was completed with a 12x6 nc balloon catheter and there were no patient complications reported.It was further reported that additional radiation and contrast were required to view the vessel while trying to remove the balloon.After removal, it was noted that the balloon failed to rewrap.Additionally, the previously implanted stent was a 12mm synergy xd drug-eluting stent.
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 and shaft kinks to the device.There was blood and contrast to the inflation lumen and the balloon.There was blood in the guidewire lumen, and the balloons were found to be loosely folded.The proximal portion of the inflation lumen (from midshaft bond to the rpe) was stretched and fully separated just distal to the rapid port exchange (rpe).The guidewire lumen was stretched from the rpe moving distal for a length of 3mm.There was twisting to the shaft and the balloon of the device.There was full detachment of the guidewire lumen within the shaft (inflation lumen) at the distal waist.There was visible texture noted to the distal portion of the balloon, and the tip of the device was damaged.Product analysis confirmed the reported separation and removal difficulties as the inflation lumen and guidewire lumen were separated and the stretched and twisted shaft damage to the device indicate procedural and removal difficulties.
Event or Problem Description
It was reported that difficulty removal and shaft break occurred requiring an additional intervention.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified left main (lm) artery.A 6.00mm x 8mm nc emerge balloon catheter was advanced for post-dilatation.However, during withdrawal after deflation, the balloon was stuck in the lm implanted stent.When physician applied force to remove the balloon, the shaft was fractured at about 15cm from the distal tip.The balloon and the rest of the shaft left inside the patient's coronary artery.The fragment was snared out of the body successfully.This required a prolonged procedure with additional radiation and blood loss.The procedure was completed with a 12x6 nc balloon catheter and there were no patient complications 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15510558
• Report Number: 2124215-2022-37449
• Device Sequence Number: 14745251
• Product Code: LOX
• UDI-Device Identifier: 08714729846345
• UDI-Public: 08714729846345
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 11/30/2022

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: 02/22/2023
• Device Model Number: 7211
• Device Catalogue Number: 7211
• Device Lot Number: 0026848332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2022
• Supplement Date Received by Manufacturer: 11/08/2022; 11/22/2022
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 11/18/2022; 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2021
• 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; Other
• Patient Sex: Unknown