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

Model Number 6533

Device Problem Break (1069)

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

Event Date 04/01/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: the date of event is unknown.The complaint was reported to bsc on (b)(6) apr-2019.Therefore, a date of (b)(6) 2019 was entered to report the event occurring on an unknown date in (b)(6) 2019.

Event Description

It was reported that a shaft break occurred.While advancing a 20 mm x 3.50 mm nc quantum apex in a complex lesion, the shaft broke.The device was removed intact and the procedure was completed with another of the same device.No patient complications were reported in relation to this event and the patient status was stable.

Manufacturer Narrative

Date of event: the date of event is unknown.The complaint was reported to bsc on 10-apr-2019.Therefore, a date of (b)(6) 2019 was entered to report the event occurring on an unknown date in (b)(6) 2019.Device evaluated by mfr: returned product consisted of a nc quantum apex balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded.There were numerous hypotube kinks throughout the device.There was a complete hypotube separation 66.5cm distal of the strain relief.The hypotube fracture surfaces were ovaled, which suggests the device was kinked prior to separation.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that a shaft break occurred.While advancing a 20mm x 3.50mm nc quantem apex in a complex lesion, the shaft broke.The device was removed intact and the procedure was completed with another of the same device.No patient complications were reported in relation to this event and the patient status was stable.

• 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
• MDR Report Key: 8579406
• MDR Text Key: 144531350
• Report Number: 2134265-2019-04637
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729783503
• UDI-Public: 08714729783503
• 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,Followup
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2020
• Device Model Number: 6533
• Device Catalogue Number: 6533
• Device Lot Number: 0020568828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2019
• Date Manufacturer Received: 05/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1