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

Model Number	7214
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/02/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2018.It was reported that wire loading difficulty was encountered.A 3.50mm x 20mm nc emerge balloon catheter was used but failed to load over the 0.14 guide wire as expected.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed hole in wire lumen.Returned product consisted of a nc emerge balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed buckling and a hole on the guidewire lumen 4.7cm from the tip.The hole in the guidewire lumen is consistent with a guidewire puncturing it.The balloon is loosely folded.The guide wire used in the clinical procedure was not returned with the device so a test guide wire was used for functional testing.Per product specification test, a.014" test guide wire was advanced into the guide wire lumen and was unable to pass the buckled section.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 8162754
• Report Number: 2134265-2018-64054
• Device Sequence Number: 2370570
• Product Code: LOX
• UDI-Device Identifier: 08714729846673
• UDI-Public: 08714729846673
• Combination Product (Y/N): N
• PMA/510(K) Number: K141236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/13/2018

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: 06/19/2020
• Device Model Number: 7214
• Device Catalogue Number: 7214
• Device Lot Number: 0022275685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 12/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR