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

Model Number	6533
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that shaft break occurred.A 20mm x 3.00mm nc quantum apex balloon catheter was selected for use; however, when the device was removed from the package, it was noticed that the hypotube was fractured.The procedure was completed with another of the same device.No patient complications reported and the patient's status was stable.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).Device evaluated by mfr.:returned product consisted of a nc quantum apex mr balloon catheter.The balloon was tightly folded.Analysis of the tip, balloon, inner/outer shaft, and hypotube included microscopic and visual inspection.Inspection revealed numerous kinks in the hypotube.Inspection of the rest of the device found no other damage or defects.
Event or Problem Description
It was reported that shaft break occurred.A 20mm x 3.00mm nc quantum apex balloon catheter was selected for use; however, when the device was removed from the package, it was noticed that the hypotube was fractured.The procedure was completed with another of the same device.No patient compications reported and the patient's status was stable.

• 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: 9482795
• Report Number: 2134265-2019-15838
• Device Sequence Number: 10821695
• Product Code: LOX
• UDI-Device Identifier: 08714729783480
• UDI-Public: 08714729783480
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K121667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2020

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: 10/24/2022
• Device Model Number: 6533
• Device Catalogue Number: 6533
• Device Lot Number: 0024657497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 03/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR