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

Model Number	7213
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
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 balloon detachment occurred.The target lesion was located in the mildly calcified mid circumflex artery.After a stent was inflated, a perforation was noted.The 4.00mm x 15mm nc emerge balloon catheter was inflated two times for 2-3 minutes for tamponade.The balloon was removed and reinserted for tamponade two more times for 2-3 minutes.When an attempt was made to remove the balloon after the final deflation, heavy resistance was encountered.The balloon was pulled into the left main where it would not pull on the guide.The physician pulled a second time and the balloon shaft broke away from the balloon.The balloon was still on the wire and the proximal shoulder was wedged in the guide enough to remove everything as a whole until the entire system became entrapped in the brachial artery.An additional wire was used as a buddy wire next to the wire/balloon through the guide to assist.The buddy wire got wrapped in the balloon material enough to allow for the entire system to be pulled out of the sheath.A new guide and wire was inserted and a covered stent was delivered to the mid circumflex perforation with successful deployment and seal.The patient did not have a direct complication from the balloon fracture, however, the fracture prolonged the ability to provide treatment of a life threatening complication.
Additional Manufacturer Narrative
Returned product consisted of an nc emerge balloon catheter.The device was visually and microscopically examined.A stopcock was still attached at the manifold of the device upon return.The manifold contained blood, and there were numerous hypotube kinks.There was blood and contrast present in the inflation lumen and balloon.There was blood in the guidewire lumen and the balloon was loosely folded.At 121.8cm from the strain relief the shaft was separated.The inflation lumen and guidewire lumen to the device was stretched for a total length of 25.1cm.
Event or Problem Description
It was reported that balloon detachment occurred.The target lesion was located in the mildly calcified mid circumflex artery.After a stent was inflated, a perforation was noted.The 4.00mm x 15mm nc emerge balloon catheter was inflated two times for 2-3 minutes for tamponade.The balloon was removed and reinserted for tamponade two more times for 2-3 minutes.When an attempt was made to remove the balloon after the final deflation, heavy resistance was encountered.The balloon was pulled into the left main where it would not pull on the guide.The physician pulled a second time and the balloon shaft broke away from the balloon.The balloon was still on the wire and the proximal shoulder was wedged in the guide enough to remove everything as a whole until the entire system became entrapped in the brachial artery.An additional wire was used as a buddy wire next to the wire/balloon through the guide to assist.The buddy wire got wrapped in the balloon material enough to allow for the entire system to be pulled out of the sheath.A new guide and wire was inserted and a covered stent was delivered to the mid circumflex perforation with successful deployment and seal.The patient did not have a direct complication from the balloon fracture, however, the fracture prolonged the ability to provide treatment of a life threatening complication.

• 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: 12866316
• Report Number: 2134265-2021-14802
• Device Sequence Number: 6120285
• Product Code: LOX
• UDI-Device Identifier: 08714729846567
• UDI-Public: 08714729846567
• 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): 02/02/2022

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: 10/06/2023
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0028149781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2022
• 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: 02/01/2022
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2021
• 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