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	07/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break occurred.The patient presented with coronary artery disease.The 100% stenosed target lesion was located in the severely calcified and non-tortuous superficial femoral artery.A 5.00mm x 20mm nc emerge balloon catheter was advanced for dilation.The shaft of the balloon catheter broke apart inside the patient during removal.The physician used a guide catheter and a threader device to trap the device fragment.The device was removed from the patient in two pieces and the procedure was completed.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 visually and microscopically examined.There were numerous kinks to the hypotube and shaft of the device.There was blood and contrast within the inflation lumen and the balloon.There was blood in the guidewire lumen and the balloon was loosely folded.At 4.8cm distal to the midshaft bond, the shaft was separated.The proximal portion of the shaft separation was stretched for a length of 3.9cm.The distal portion of the shaft separation was stretched for a length of 7mm.The rapid port exchange (rpe) was torn 11mm in length moving distal from the rpe.At 3mm distal from the bicomponent weld, the guidewire lumen was buckled for a length of 1mm.There was tip damage to the device.
Event or Problem Description
It was reported that shaft break occurred.The patient presented with coronary artery disease.The 100% stenosed target lesion was located in the severely calcified and non-tortuous superficial femoral artery.A 5.00mm x 20mm nc emerge balloon catheter was advanced for dilation.However, it was noted that the shaft of the balloon catheter broke apart inside the patient during removal.The physician used a guide catheter and a threader device to trap the device fragment.Subsequently, the broken pieces were retrieved from the patient and the procedure was completed.There were no patient complications reported.

• Brand Name: NC EMERGE
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17510864
• Report Number: 2124215-2023-39857
• Device Sequence Number: 7927982
• Product Code: LOX
• UDI-Device Identifier: 08714729846710
• UDI-Public: 08714729846710
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 09/14/2023

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: 03/25/2025
• Device Model Number: 7214
• Device Catalogue Number: 7214
• Device Lot Number: 0031308009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2023
• Supplement Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2023
• 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