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

Model Number	6532
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 15mm x 4.00mm nc quantum apex balloon catheter was selected for dilatation.However, during inflation at 10 atmospheres, the balloon ruptured.No patient complications were reported.
Event or Problem Description
It was reported that balloon rupture occurred.A 15mm x 4.00mm nc quantum apex balloon catheter was selected for dilatation.However, during inflation at 10 atmospheres, the balloon ruptured.No patient complications were reported.Device evaluated by mfr.: the outer shaft, inner shaft, balloon and tip were microscopically examined.Microscopic examination revealed that the balloon has a 9mm longitudinal tear starting at the proximal balloon cone.The shaft is damaged at the exit notch.Inspection of the remainder of the device presented no other damage or irregularities.There was no evidence of any material or manufacturing deficiencies contributing to the damage and the reported event.

• 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: 7973747
• Report Number: 2134265-2018-61964
• Device Sequence Number: 11156168
• Product Code: LOX
• UDI-Device Identifier: 08714729783411
• UDI-Public: 08714729783411
• 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): 11/30/2018

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: 07/10/2021
• Device Model Number: 6532
• Device Catalogue Number: 6532
• Device Lot Number: 0022358889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Initial Date Received by Manufacturer: 09/21/2018
• Supplement Date Received by Manufacturer: 11/04/2018
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 12/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1