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

Model Number	7215
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/26/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulties were encountered.The target lesion was located in the right coronary artery (rca).After deploying a synergy stent in the distal rca, a 3.50mm x 30mm nc emerge balloon catheter was advanced for post-dilation.However, during removal, the shaft hung up and accordioned on the wire.Eventually, the device was successfully removed by pulling it hard.Another 2.50mm x 30mm nc emerge balloon catheter was advanced for post-dilation in proximal rca and also got hung up on the wire.The device was removed as well and the procedure was completed.No patient complications were reported.
Additional Manufacturer Narrative
Returned product consisted of a nc emerge balloon catheter.The balloon was loosely folded and there was blood in the wire lumen.The tip, balloon, markerbands, inner/outer shaft, and hypotube were microscopically and visually inspected.Inspection revealed tip damage (flared), numerous kinks in the hypotube, port weld/exit notch damage, balloon damage (bunched up) for the entire length of the balloon, and inner shaft damage (buckling) for a length of 25 mm.The tip and exit notch of the device was measured with a calibrated pin gage.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The guide wire used in the procedure was not returned for analysis.Functional testing was conducted with a lab supplied.014 guide wire.The guide wire was loaded into the exit notch and backloaded into the tip.The functional test was executed multiple times, with different results.The wire advanced easily the first attempt (loaded through exit notch) but became stuck when backloaded into the tip.The wire was then loaded again into the exit notch and became stuck once the wire reached the balloon area and couldn't be removed.The balloon was deflated and again backloaded into the tip, but the wire was then able to easily pass through the lumen.
Event or Problem Description
It was reported that removal difficulties were encountered.The target lesion was located in the right coronary artery (rca).After deploying a synergy stent in the distal rca, a 3.50mm x 30mm nc emerge balloon catheter was advanced for post-dilation.However, during removal, the shaft hung up and accordioned on the wire.Eventually, the device was successfully removed by pulling it hard.Another 2.50mm x 30mm nc emerge balloon catheter was advanced for post-dilation in proximal rca and also got hung up on the wire.The device was removed as well and the procedure was completed.No patient complications were 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: 8160822
• Report Number: 2134265-2018-64037
• Device Sequence Number: 11312238
• Product Code: LOX
• UDI-Device Identifier: 08714729846765
• UDI-Public: 08714729846765
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 01/14/2019

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 Expiration Date: 08/16/2020
• Device Model Number: 7215
• Device Catalogue Number: 7215
• Device Lot Number: 0022529999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Initial Date Received by Manufacturer: 11/26/2018
• Supplement Date Received by Manufacturer: 12/20/2018
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 01/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PROWATER GUIDE WIRE; PROWATER GUIDE WIRE; SYNERGY STENT; SYNERGY STENT; PROWATER GUIDE WIRE; SYNERGY STENT