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

Model Number	7015
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulties were encountered.The patient presented with acute myocardial infarction.The 80% stenosed target lesion was located in the non-tortuous and non-calcified left anterior descending artery.A 4.0mm x 15mm quantum maverick balloon catheter was advanced for dilation.However, there was difficulty advancing the device on the lesion site and difficulty pulling back the balloon.The device was successfully removed and the procedure was completed with another of same device.There were no patient complications nor injuries reported and the patient status was stable.
Additional Manufacturer Narrative
(b)(6).
Additional Manufacturer Narrative
E1 initial reporter address 1: (b)(6).(e1) initial reporter first name, initial reporter last name and initial reporter phone: corrected.
Event or Problem Description
It was reported that removal difficulties were encountered.The patient presented with acute myocardial infarction.The 80% stenosed target lesion was located in the non-tortuous and non-calcified left anterior descending artery.A 4.0mm x 15mm quantum maverick balloon catheter was advanced for dilation.However, there was difficulty advancing the device on the lesion site and difficulty pulling back the balloon.The device was successfully removed and the procedure was completed with another of same device.There were no patient complications nor injuries reported and the patient status was stable.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13361116
• Report Number: 2134265-2022-00660
• Device Sequence Number: 16559669
• Product Code: LOX
• UDI-Device Identifier: 08714729392828
• UDI-Public: 08714729392828
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P860019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2022

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: 11/25/2022
• Device Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0024832315
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2022
• Supplement Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 01/26/2022
• Supplement Report FDA Received Date: 01/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Female