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

Model Number	6531
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device analysis: returned product consisted of a nc quantum apex balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined and revealed contrast in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded.Inspection of the device revealed numerous kinks throughout the hypotube.A complete hypotube separation 49cm distal of the strain relief.The hypotube fracture surfaces were oval, which suggests the device was kinked prior to separation.
Event or Problem Description
It was reported that shaft break occurred.The target lesion is located in the right coronary artery.Following stent implantation, a 12mm x 2.75mm nc quantum apex balloon catheter was advanced for post dilatation.However, while inserting the device into the guide, the balloon catheter broke halfway from the hub.The procedure was completed with another of the same device.No patient complications were reported and the patient was not harmed.

• 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: 9688363
• Report Number: 2134265-2020-01079
• Device Sequence Number: 3350881
• Product Code: LOX
• UDI-Device Identifier: 08714729783251
• UDI-Public: 08714729783251
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K121667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/10/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/09/2022
• Device Model Number: 6531
• Device Catalogue Number: 6531
• Device Lot Number: 0024573662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 02/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1