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

Model Number	6531
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Device evaluated by mfr: returned product consisted of an 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 loosely folded.Inspection of the device revealed numerous kinks throughout the hypotube and there was a complete hypotube separation 43.5cm distal of the strain relief.The hypotube fracture surfaces were ovaled, which suggests the device was kinked prior to separation.Also, the tip was damaged.
Event or Problem Description
Reportable based on device analysis completed on 03/05/2020.It was reported that the shaft was damaged.A 12mm x 2.50mm nc quantum apex was selected however, during unpacking, it was noted that the shaft was damaged.The procedure was completed with a different device.No patient complications were reported and patient status was stable.However, device analysis revealed a shaft break.

• 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: 9884870
• Report Number: 2134265-2020-03500
• Device Sequence Number: 492580
• Product Code: LOX
• UDI-Device Identifier: 08714729783244
• UDI-Public: 08714729783244
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K121667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/26/2020

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: 04/07/2022
• Device Model Number: 6531
• Device Catalogue Number: 6531
• Device Lot Number: 0023607075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 03/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1