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

Model Number	7015
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast in the inflation lumen and balloon.The balloon was still folded but was loose and not tightly folded, indicating there was some pressure applied to the balloon.Functional testing was performed with an inflation device filled with water that was connected to the inflation device.The device was inflated; however, was unable to maintain constant pressure, as there was a leak coming from the balloon.Inspection of the balloon revealed that there was a 2mm longitudinal tear 3mm proximal of the edge of the distal markerband.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the failure to inflate, due to the balloon tear.
Event or Problem Description
Reportable based on device analysis completed on 21may2019.It was reported that inflation failure occurred.The 90% stenosed, 15mmx3.5mm target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 3.5mm x 15mm quantum maverick balloon catheter was advanced for dilation but would not inflate despite pressure applied.There were no visible pinhole noted on the balloon material.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, device analysis revealed balloon torn longitudinal.

• Brand Name: QUANTUM MAVERICK
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8691055
• Report Number: 2134265-2019-06074
• Device Sequence Number: 19337071
• Product Code: LOX
• UDI-Device Identifier: 08714729392804
• UDI-Public: 08714729392804
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P860019
• 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
• Report Date (Section B): 06/12/2019

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: 12/20/2021
• Device Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0023114033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 06/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 52