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

Model Number	6530
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter entrapment occurred.The target lesion was located in the tortuous and non calcified right coronary artery.After a 190cm samurai guide wire was crossed the lesion, a 8mm x 2.50mm nc quantum apex was advanced for post-dilation.However, it was noted that the guide wire became stuck with the balloon catheter.The wire and the balloon were removed together.Then the physician and scrub tech tried to removed the balloon from the wire out side the patient's body but it could not removed even great force was apply, after several attempt the wire basically broke at some point in the monorail segment of the balloon where it was stuck and started to unravel.The procedure was completed with a marvel guide wire.No patient complications nor injuries were reported.Returned product consisted of a nc quantum apex balloon catheter with the samurai guidewire for the related complaint in the shaft.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.There were numerous kinks throughout the hypotube and shaft.The wire was stretched the entire length of the shaft (from the exit notch to the tip).Majority of the outer and inner shafts were buckled, not allowing the guidewire to be removed.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 8051363
• Report Number: 2134265-2018-62659
• Device Sequence Number: 1787736
• Product Code: LOX
• UDI-Device Identifier: 08714729783138
• UDI-Public: 08714729783138
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K121667
• 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
• Report Date (Section B): 11/08/2018

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: 09/11/2021
• Device Model Number: 6530
• Device Catalogue Number: 6530
• Device Lot Number: 0022645339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2018
• Initial Report FDA Received Date: 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1