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

Model Number 6530

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/24/2019

Event Type  malfunction  

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 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
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9438028
• MDR Text Key: 175901392
• Report Number: 2134265-2019-15080
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729783152
• UDI-Public: 08714729783152
• Combination Product (y/n): N
• PMA/PMN Number: K121667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/02/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1