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

Model Number	6532
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a diagonal lesion of a coronary artery.A 15mm x 3.00mm nc quantum apex balloon catheter was inserted but the balloon was not exiting the guide catheter.When the device was took out, it was noticed that the hypotube was broken.Physician used a new guide and wire and continued the intervention without complications.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a diagonal lesion of a coronary artery.A 15mm x 3.00mm nc quantum apex balloon catheter was inserted but the balloon was not exiting the guide catheter.When the device was took out, it was noticed that the hypotube was broken.Physician used a new guide and wire and continued the intervention without complications.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a nc quantum apex balloon catheter in two pieces.The balloon was tightly folded, and the device was bloody.Analysis of the tip, balloon, markerbands, inner/outer shaft and hypotube included microscopic and visual inspection.Inspection revealed a complete separation in the hypotube, located 78cm from the tip of the device.Inspection of the rest of the rest of the device found no other damage or defect.

• 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: 9216463
• Report Number: 2134265-2019-12577
• Device Sequence Number: 345521
• Product Code: LOX
• UDI-Device Identifier: 08714729783374
• UDI-Public: 08714729783374
• 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,Followup
• Report Date (Section B): 12/05/2019

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 Model Number: 6532
• Device Catalogue Number: 6532
• Device Lot Number: 0024212671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Initial Date Received by Manufacturer: 10/04/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 10/21/2019
• Supplement Report FDA Received Date: 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR