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

Model Number	6531
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 a kink on the hypotube 8.5cm from the hub.The guidewire lumen is kinked 1mm and 15mm from the tip.Microscopic examination revealed that the tip is damaged.There is a longitudinal tear in the balloon 9mm from the tip and approximately 5mm long.There is contrast present in the inflation lumen and balloon.There is blood present in the guidewire lumen and the balloon is loosely folded.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
Reportable based on device analysis completed on 21-feb-2019.It was reported that crossing difficulties were encountered.Vascular access was obtained via the femoral artery.The 85% stenosed, 28x3mm, concentric target lesion was located in the mildly tortuous and mildly calcified right coronary artery.The lesion contained between a 45 and 95 degree bend.A 12mm x 2.50mm nc quantum apex balloon catheter was advanced but failed to cross the lesion.The procedure was completed with a different device.No patient complications were reported.However, returned device analysis revealed balloon longitudinal tear.

• 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: 8436583
• Report Number: 2134265-2019-02751
• Device Sequence Number: 277961
• Product Code: LOX
• UDI-Device Identifier: 08714729783244
• UDI-Public: 08714729783244
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K121667
• 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): 03/20/2019

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: 07/10/2021
• Device Model Number: 6531
• Device Catalogue Number: 6531
• Device Lot Number: 0022358491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 03/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1