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

Model Number	7213
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/30/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 2.75mm x 15mm nc emerge balloon catheter was inserted over the wire.However, the device experienced difficulties advancing through the guide catheter prior reaching the coronary anatomy.The negative was pulled from the balloon and blood was noted in the contrast.Subsequently, the balloon was completely removed for further inspection and it was noted that the shaft was broken or snapped.The device was replaced and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.
Event or Problem Description
It was reported that shaft break occurred.A 2.75mm x 15mm nc emerge balloon catheter was inserted over the wire.However, the device experienced difficulties advancing through the guide catheter prior reaching the coronary anatomy.The negative was pulled from the balloon and blood was noted in the contrast.Subsequently, the balloon was completely removed for further inspection and it was noted that the shaft was broken or snapped.The device was replaced and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.Returned product consisted of a nc emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was blood in the inflation and guidewire lumens.The balloon was tightly folded.There were numerous kinks throughout the device.There was a complete hypotube separation 43.5cm distal of the strain relief.The hypotube fracture surfaces were ovaled.The guide catheter used in the procedure was not returned for analysis, so a test 5f guide catheter was used.The tip of the device was inserted through the hub of the guide catheter and the nc emerge was advanced with no issues up to the separated end.Inspection of the remainder of the device presented no other damage or irregularities.The complaint investigation conclusion code is: adverse event related to 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: 7818935
• Report Number: 2134265-2018-60407
• Device Sequence Number: 13774788
• Product Code: LOX
• UDI-Device Identifier: 08714729846512
• UDI-Public: 08714729846512
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2018

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: 05/08/2020
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0022094374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2018
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 10/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1