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

Model Number	7214
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that froze on wire occurred.During a procedure involving a 3.75 x 20mm nc emerge balloon, the balloon froze on the wire inside the patient's body.Both devices were removed together.Once outside the body, the balloon shaft fractured as the physician was trying to remove it from the wire.
Event or Problem Description
It was reported that froze on wire occurred.During a procedure involving a 3.75 x 20mm nc emerge balloon, the balloon froze on the wire inside the patient's body.Both devices were removed together.Once outside the body, the balloon shaft fractured as the physician was trying to remove it from the wire.
Additional Manufacturer Narrative
Device returned to manufacturer: the nc emerge balloon catheter was returned with a non-bsc guidewire inside the distal portion of the device.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was loosely folded.Inspection of the device revealed that there were numerous kinks throughout the hypotube.The shaft was detached right after the exit notch of the device, which was 29cm proximal of the tip.The wire lumen was buckled at the distal end of the balloon for 1cm.An attempt to remove the guidewire was unsuccessful due to the buckled wire lumen.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported event as the guidewire was stuck inside the distal portion of the device and the shaft detached.

• 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: 9126366
• Report Number: 2134265-2019-11595
• Device Sequence Number: 16797962
• Product Code: LOX
• UDI-Device Identifier: 08714729846680
• UDI-Public: 08714729846680
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 10/29/2019

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: 7214
• Device Catalogue Number: 7214
• Device Lot Number: 0023888457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Initial Date Received by Manufacturer: 09/06/2019
• Supplement Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 10/29/2019
• Patient Sequence Number: 1