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

Model Number	7015
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the label was incorrect.A 2.5mm x 15mm quantum maverick balloon catheter was selected for use.However, it was noticed that the device model was incorrect.There were no patient complications and the patient was stable.
Event or Problem Description
It was reported that the label was incorrect.A 2.5mm x 15mm quantum maverick balloon catheter was selected for use.However, it was noticed that the device model was incorrect.There were no patient complications and the patient was stable.It was further reported that the stent was shorter than the estimated lesion.
Additional Manufacturer Narrative
Updated b5: describe event or problem.

• 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: 10774257
• Report Number: 2134265-2020-14935
• Device Sequence Number: 3814501
• Product Code: LOX
• UDI-Device Identifier: 08714729392767
• UDI-Public: 08714729392767
• 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): 11/16/2020

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: 10/20/2022
• Device Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0024628860
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 11/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 68