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

Model Number 6531

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

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

Event Date 12/05/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.The device was removed from the guidezilla ii.Visual examination revealed that the balloon is separated 1cm from the tip.There are multiple kinks along the hypotube.Microscopic examination revealed that the guidewire lumen is stretched from the tip to 9cm from the tip.There is multiple buckling in the stretched area.The guidewire was attempted to be removed but it appears to be stuck because of the damages so it was left in place.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

Reportable based on device analysis completed on 19dec2019.A 12mmx3.50mm nc quantum apex was returned with no reported issues.However, device analysis revealed balloon separation.

• 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 SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9575964
• MDR Text Key: 178011244
• Report Number: 2134265-2019-16572
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729783282
• UDI-Public: 08714729783282
• 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,health
• Type of Report: Initial
• Report Date: 01/10/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2022
• Device Model Number: 6531
• Device Catalogue Number: 6531
• Device Lot Number: 0024164251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Initial Date Manufacturer Received: 12/19/2019
• Initial Date FDA Received: 01/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2019
• 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