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

Model Number	6530
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an nc quantum apex balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was a kink 83cm distal from the strain relief.There was contrast and blood in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.Microscopic inspection revealed tip damage.There was a longitudinal tear 9mm long starting 1mm proximally from the proximal marker band.The device was functionally tested with a.014 inch.The guidewire was unable to advance past the proximal marker band due to a kink on the inner shaft.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found a longitudinal tear on the balloon and was unable to fully insert a guidewire.
Event or Problem Description
Reportable based on device analysis completed on 26nov2019.A 8mm x 3.00mm nc quantum apex balloon catheter was received with no issues reported.However, returned device analysis revealed a balloon torn longitudinal.

• 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: 9438028
• Report Number: 2134265-2019-15080
• Device Sequence Number: 3623098
• Product Code: LOX
• UDI-Device Identifier: 08714729783152
• UDI-Public: 08714729783152
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/09/2019

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: 01/01/2022
• Device Model Number: 6530
• Device Catalogue Number: 6530
• Device Lot Number: 0023124068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 12/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1