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

Model Number	6533
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that balloon rupture occurred.The 3mm target lesion was located in the non calcified left coronary artery.A 20mm x 2.00mm nc quantum apex balloon catheter was advanced for pre-dilation.However, during inflation at 12 atmospheres, the balloon ruptured.The device was removed from the patient and the procedure was completed with another 2.5x15mm nc quantum balloon catheter and implantation of two stent's.No patient complications nor injuries were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a nc quantum apex balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks along the hypotube.Microscopic examination revealed a longitudinal tear 5.5mm from the tip and approximately 9mm long.There is contrast present in the inflation lumen and balloon.There is blood present in the guidewire lumen and the balloon is loosely folded.The reported information indicates the device was inflated to 12atm; therefore, there is no indication the device was inflated over rbp.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon rupture occurred.The 3mm target lesion was located in the non calcified left coronary artery.A 20mm x 2.00mm nc quantum apex balloon catheter was advanced for pre-dilation.However, during inflation at 12 atmospheres, the balloon ruptured.The device was removed from the patient and the procedure was completed with another 2.5x15mm nc quantum balloon catheter and implantation of two stent's.No patient complications nor injuries were reported.

• 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: 7977933
• Report Number: 2134265-2018-61736
• Device Sequence Number: 13798212
• Product Code: LOX
• UDI-Device Identifier: 08714729783442
• UDI-Public: 08714729783442
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Followup
• Report Date (Section B): 02/08/2019

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: 01/16/2021
• Device Model Number: 6533
• Device Catalogue Number: 6533
• Device Lot Number: 0021621844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Initial Date Received by Manufacturer: 09/25/2018
• Supplement Date Received by Manufacturer: 01/18/2019
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 02/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1