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

Model Number	6532
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter entrapment and shaft break occurred.A 15mm x 5.00mm nc quantum apex balloon catheter was selected for use.However, upon entering a 0.14 unknown guide wire into the catheter, the balloon shaft was stuck on the wire in the guide catheter and as the physician was pushing the device, the catheter broke.The physician was able to remove everything as he pulled back the wire.A new wire and a 20x5.00mm balloon was used and completed the procedure.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Describe event or problem updated.Device evaluated by mfr.: returned product consisted of the distal end of a nc quantum apex balloon catheter and a portion of a filter guidewire.There was blood in the inflation lumen and balloon.The shaft was kinked and had numerous buckled and stretched locations throughout the shaft.The guidewire was unable to be removed due to the condition of the catheter shaft.The midshaft was separated, the end of the midshaft was jagged and stretched due to tensile overload.Measurements of the device were unable to be taken due to the condition of the device.The balloon was bunched over the tip.
Event or Problem Description
It was reported that catheter entrapment and shaft break occurred.A 15mm x 5.00mm nc quantum apex balloon catheter was selected for use.However, upon entering a 0.14 unknown guide wire into the catheter, the balloon shaft was stuck on the wire in the guide catheter and as the physician was pushing the device, the catheter broke.The physician was able to remove everything as he pulled back the wire.A new wire and a 20x5.00mm balloon was used and completed the procedure.No patient complications were reported and the patient's status was fine.It was further reported that the target lesion was located in the mildly to moderately calcified vessel of the left leg.The device was fractured mid shaft and was removed with the guide wire and guide catheter.
Additional Manufacturer Narrative
Describe event or problem updated.
Event or Problem Description
It was reported that catheter entrapment and shaft break occurred.A 15mm x 5.00mm nc quantum apex balloon catheter was selected for use.However, upon entering a 0.14 unknown guide wire into the catheter, the balloon shaft was stuck on the wire in the guide catheter and as the physician was pushing the device, the catheter broke.The physician was able to remove everything as he pulled back the wire.A new wire and a 20x5.00mm balloon was used and completed the procedure.No patient complications were reported and the patient's status was fine.It was further reported that the target lesion was located in the mild to moderately calcified vessel of the left leg.The device was fractured mid shaft and was removed with the guide wire and guide catheter.

• 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: 9503892
• Report Number: 2134265-2019-15970
• Device Sequence Number: 13938720
• Product Code: LOX
• UDI-Device Identifier: 08714729783435
• UDI-Public: 08714729783435
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup,Followup
• Report Date (Section B): 01/31/2020

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: 05/14/2021
• Device Model Number: 6532
• Device Catalogue Number: 6532
• Device Lot Number: 0022118410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 12/23/2019; 01/10/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 01/07/2020; 01/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1