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 Consequences Or Impact To Patient (2199)
Date of Event	03/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 damage to the guidewire lumen 42mm from the tip.The guidewire lumen is buckled 46mm from the tip and there is a hole in the guidewire lumen 47mm from the tip.The balloon is still tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage to the guidewire lumen that would prevent a guidewire from passing thru.
Event or Problem Description
Reportable based on device analysis completed on 08-apr-2019.It was reported that difficulty to load wire was encountered.A 3.50mm x 20mm nc emerge balloon catheter was selected for treatment.However, a resistance was noted during insertion of the guidewire into the balloon.They took the guidewire out and tried to put the packaging mandrel back into the wire lumen, but it was not able to pass.The procedure was completed using another of the same device.No patient complications were reported.However, returned device analysis revealed a hole in the guidewire lumen.

• 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: 8570217
• Report Number: 2134265-2019-04713
• Device Sequence Number: 16730893
• Product Code: LOX
• UDI-Device Identifier: 08714729846673
• UDI-Public: 08714729846673
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/01/2019

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: 01/17/2021
• Device Model Number: 7214
• Device Catalogue Number: 7214
• Device Lot Number: 0023209865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 05/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1