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

Model Number	6530
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a shaft break occurred.A 8mm x 3.00mm nc quantum apex balloon catheter was selected for use.During insertion of the catheter through the hemostatic valve the catheter shaft broke while outside the patient body.The nc quantum apex balloon catheter was exchanged for another same device.No patient complications were reported.The patient condition was fine.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of an nc quantum apex balloon catheter.The device was visually and microscopically examined.There was a separation of the hypotube 49.6cm from the strain relief.There was contrast in the inflation lumen.The balloon was tightly folded, and there was blood present in the folds.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported break as there was separation to the device.
Event or Problem Description
It was reported that a shaft break occurred.A 8mm x 3.00mm nc quantum apex balloon catheter was selected for use.During insertion of the catheter through the hemostatic valve the catheter shaft broke while outside the patient body.The nc quantum apex balloon catheter was exchanged for another same device.No patient complications were reported.The patient condition was fine.

• 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: 12587204
• Report Number: 2134265-2021-12538
• Device Sequence Number: 19219301
• Product Code: LOX
• UDI-Device Identifier: 08714729783152
• UDI-Public: 08714729783152
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K121667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2021

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: 02/24/2024
• Device Model Number: 6530
• Device Catalogue Number: 6530
• Device Lot Number: 0026863682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 11/01/2021
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 11/03/2021
• Patient Sequence Number: 1