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

Model Number	6533
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/07/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon ruptured occurred.A 20mm x 3.75mm nc quantum apex balloon catheter was advanced for dilation.However, during the inflation at 18 atmospheres, the balloon ruptured.No patient complications were reported.
Event or Problem Description
It was reported that balloon ruptured occurred.A 20mm x 3.75mm nc quantum apex balloon catheter was advanced for dilation.However, during the inflation at 18 atmospheres, the balloon ruptured.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks along the whole device.The inflation lumen is separated 115.2cm from the hub.Based on the location of the separation a pressure test could not be performed.The inflation lumen is stretched 30.8cm from the tip and goes to the separation.Microscopic examination revealed a hole in the inflation lumen at 112.7cm from the hub and the tip is damaged.The guidewire lumen is stretched and prolapsed 4.6cm from the tip.There is blood present in the inflation lumen and balloon.The balloon is loosely folded.Review of the product specification indicates the rated burst pressure (rbp) of the complaint device is 20atm.The reported information indicates the device was inflated to 18atm; therefore, there is no indication the device was inflated over rbp.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis did not confirm any tear in the balloon.

• 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: 8212636
• Report Number: 2134265-2018-64759
• Device Sequence Number: 1987354
• Product Code: LOX
• UDI-Device Identifier: 08714729783510
• UDI-Public: 08714729783510
• 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): 02/19/2019

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 Expiration Date: 09/07/2021
• Device Model Number: 6533
• Device Catalogue Number: 6533
• Device Lot Number: 0022624586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Initial Date Received by Manufacturer: 12/14/2018
• Supplement Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 01/03/2019
• Supplement Report FDA Received Date: 02/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1