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

Model Number	6532
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/21/2018
Type of Reportable Event	Malfunction
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 that the inflation lumen and guidewire lumen is flattened 2.9cm from the tip and approximately 21.4cm long.Microscopic examination revealed that the inflation lumen and guidewire lumen has a longitudinal tear 24cm from the tip and approximately 7mm long.The tip is also damaged.There is contrast present in the inflation lumen and the balloon is still tightly 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.Test guide wire was advanced into the guide wire lumen and was unable to pass thru the flattened section.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2019.It was reported that advancing difficulties through the guide were encountered.A 15mm x 3.75mm nc quantum apex balloon catheter was advanced for dilation.However, it was noted that the balloon would not advance through the guide.The procedure was completed with a different device.No patient complications were reported.However, 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: 8426135
• Report Number: 2134265-2019-02543
• Device Sequence Number: 2170519
• Product Code: LOX
• UDI-Device Identifier: 08714729783404
• UDI-Public: 08714729783404
• 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
• Report Date (Section B): 03/15/2019

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: 08/12/2021
• Device Model Number: 6532
• Device Catalogue Number: 6532
• Device Lot Number: 0022503245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 03/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1