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

Model Number	7020
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the package seal was broken.During preparation of a 2.5mm x 20mm quantum maverick balloon catheter, it was noted that the seal of the aseptic packaging was broken.The procedure was completed with another of the same device.No patient complications were reported.
Event or Problem Description
It was reported that the package seal was broken.During preparation of a 2.5mm x 20mm quantum maverick balloon catheter, it was noted that the seal of the aseptic packaging was broken.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Returned product consisted of a quantum maverick balloon catheter with the shelf box and pouch.The packaging was open but there was no damage found to the box, hoop or pouch.The hypotube was separated 75cm from hub, the separated ends were ovaled indicating that the hypotube was kinked prior to separating.There were numerous kinks throughout the catheter.The balloon was tightly folded indicating the device was not pressurized.

• 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: 9398026
• Report Number: 2134265-2019-14374
• Device Sequence Number: 2648377
• Product Code: LOX
• UDI-Device Identifier: 08714729392873
• UDI-Public: 08714729392873
• 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,Followup
• Report Date (Section B): 01/14/2020

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: 11/29/2021
• Device Model Number: 7020
• Device Catalogue Number: 7020
• Device Lot Number: 0023010989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 12/30/2019
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 01/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 77