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

Model Number	6534
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/23/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter entrapment occurred.A 30mm x 2.25mm nc quantum apex balloon catheter was advanced for dilation.Following balloon deflation, the device became trapped on the guidewire.The guidewire was moved from the coronary when the balloon was removed.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a nc quantum apex balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks along the whole device.Microscopic examination revealed buckling to the inflation lumen and guidewire lumen 96mm from the tip and approximately 17mm long.There are two more buckling to the guidewire lumen 4mm from the tip approximately 12mm long and 52mm from the tip approximately 8mm long.The tip is damaged and there is a partial separation at the exit notch that looks like it cracked open.There is blood present in the guidewire lumen and 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.A.014 inch 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.
Event or Problem Description
It was reported that catheter entrapment occurred.A 30mm x 2.25mm nc quantum apex balloon catheter was advanced for dilation.Following balloon deflation, the device became trapped on the guidewire.The guidewire was moved from the coronary when the balloon was removed.No patient complications were reported.

• Brand Name: NC QUANTUM APEX
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8166024
• Report Number: 2134265-2018-63958
• Device Sequence Number: 19519249
• Product Code: LOX
• UDI-Device Identifier: 08714729783565
• UDI-Public: 08714729783565
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K121667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2019

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: 04/20/2021
• Device Model Number: 6534
• Device Catalogue Number: 6534
• Device Lot Number: 0022021245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Initial Date Received by Manufacturer: 11/26/2018
• Supplement Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 12/14/2018
• Supplement Report FDA Received Date: 02/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1