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

Model Number	6531
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/24/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in a moderately tortuous and severely calcified right coronary artery (rca).A 12mm x 3.50mm nc quantum apex balloon was selected for pre-dilation.However, upon second inflation at 14 barometric pressure, it was noted that the balloon ruptured.The procedure was completed with a different device.No patient complications were reported and the patient's condition was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in a moderately tortuous and severely calcified right coronary artery (rca).A 12mm x 3.50mm nc quantum apex balloon was selected for pre-dilation.However, upon second inflation at 14 barometric pressure, it was noted that the balloon ruptured.The procedure was completed with a different device.No patient complications were reported and the patient's condition was stable.
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 a kink in the hypotube 110cm from the hub.Microscopic examination revealed a longitudinal tear in the balloon 4mm from the tip and approximately 14mm long.There is blood present in the guide wire lumen and the balloon is loosely folded.There is no indication the device was inflated over rated burst pressure.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 8247893
• Report Number: 2134265-2018-65131
• Device Sequence Number: 2189806
• Product Code: LOX
• UDI-Device Identifier: 08714729783282
• UDI-Public: 08714729783282
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 02/07/2019

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: 04/30/2019
• Device Model Number: 6531
• Device Catalogue Number: 6531
• Device Lot Number: 0019179833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Initial Date Received by Manufacturer: 12/24/2018
• Supplement Date Received by Manufacturer: 01/18/2019
• Initial Report FDA Received Date: 01/15/2019
• Supplement Report FDA Received Date: 02/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR