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

Model Number	7212
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that difficulty removing a balloon occurred.A left heart catheterization percutaneous coronary intervention (lhc/pci) was performed on a patient diagnosed with coronary artery disease (cad).A 3.00mm x 12mm nc emerge balloon was selected for treatment, but it unable to be seen under fluoro when inflated.It was noted that the device was prepped appropriately with contrast solution, the atmospheres held on the indeflator without issues, and the device was pulled negative multiple times, but difficulty removing the balloon occurred.The device was removed from the patient, but once removed it was noticed that the balloon was still partially inflated.The procedure was completed using an alternative method or device.No patient complications resulted in relation to this event.
Event or Problem Description
It was reported that difficulty removing a balloon occurred.A left heart catheterization percutaneous coronary intervention (lhc/pci) was performed on a patient diagnosed with coronary artery disease (cad).A 3.00mm x 12mm nc emerge balloon was selected for treatment, but it unable to be seen under fluoro when inflated.It was noted that the device was prepped appropriately with contrast solution, the atmospheres held on the indeflator without issues, and the device was pulled negative multiple times, but difficulty removing the balloon occurred.The device was removed from the patient, but once removed it was noticed that the balloon was still partially inflated.The procedure was completed using an alternative method or device.No patient complications resulted in relation to this event.It was further reported that the target lesion was located in the mid right coronary artery (rca).The patient was reported to be stable following the procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of an nc emerge balloon catheter.The device was visually and microscopically examined.The hypotube of the device has numerous severe kinks.There was contrast in the inflation lumen and balloon.There was blood in the guidewire lumen.The balloon was loosely folded.The device was soaked for a period of time to break up the contrast in the device.The balloon catheter was then prepped with an inflation device filled with water to inflate the device to the rated burst pressure.The severe hypotube kinks were likely preventing the device from inflating or deflating.The hypotube was cut during analysis to verify the kinks in the device were preventing inflation.From the separation, the distal end of the device was connected to a toughy and prepped with an inflation device filled with water to inflate the device to the rated burst pressure.The balloon was able to be inflated and maintained pressure as well as deflate with no issues.Product analysis confirmed the reported fail to deflate as the device could not inflate or deflate due to severe hypotube kinks which are consistent with damage that can cause removal difficulties.
Event or Problem Description
It was reported that difficulty removing a balloon occurred.A left heart catheterization percutaneous coronary intervention (lhc/pci) was performed on a patient diagnosed with coronary artery disease (cad).A 3.00mm x 12mm nc emerge balloon was selected for treatment, but it unable to be seen under fluoro when inflated.It was noted that the device was prepped appropriately with contrast solution, the atmospheres held on the indeflator without issues, and the device was pulled negative multiple times, but difficulty removing the balloon occurred.The device was removed from the patient, but once removed it was noticed that the balloon was still partially inflated.The procedure was completed using an alternative method or device.No patient complications resulted in relation to this event.It was further reported that the target lesion was located in the mid right coronary artery (rca).The patient was reported to be stable following the procedure.

• 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: 12526668
• Report Number: 2134265-2021-11945
• Device Sequence Number: 4102643
• Product Code: LOX
• UDI-Device Identifier: 08714729846390
• UDI-Public: 08714729846390
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2023
• Device Model Number: 7212
• Device Catalogue Number: 7212
• Device Lot Number: 0027219463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Initial Date Received by Manufacturer: 09/10/2021
• Supplement Date Received by Manufacturer: 10/05/2021; 10/18/2021
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 10/14/2021; 10/22/2021
• Patient Sequence Number: 1