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

Model Number	7213
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 3.00mm x 15mm nc emerge balloon catheter was used in a procedure.However, the rail on balloon broke while in use.The procedure was completed with a different device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an nc emerge balloon catheter, in two pieces.The balloon was loosely folded.The device was stuck on a guide wire.Analysis of the tip, balloon, markerbands, inner/outer shaft and hypotube included microscopic and visual inspection.Inspection revealed a complete separation of the inner shaft at the distal end of the port/exit notch, and a complete separation of the balloon (circumferential tear) 9mm from the distal edge, and the inner shaft was stretched down on the wire, and there were numerous kinks in the hypotube.Inspection of the rest of the rest of the device found no other damage or defect.The reported broken balloon was confirmed.
Event or Problem Description
It was reported that shaft break occurred.A 3.00mm x 15mm nc emerge balloon catheter was used in a procedure.However, the rail on balloon broke while in use.The procedure was completed with a different device.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
• MDR Report Key: 9318223
• Report Number: 2134265-2019-13561
• Device Sequence Number: 10857865
• Product Code: LOX
• UDI-Device Identifier: 08714729846529
• UDI-Public: 08714729846529
• 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): 12/05/2019

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 Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0024103782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Initial Date Received by Manufacturer: 10/23/2019
• Supplement Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR