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

Model Number	7590
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon deflation issues occurred.The target lesion, which was 100% stenosed, was located in the moderately tortuous and mildly calcified right coronary artery (rca).A 6f guide catheter was utilized and a 2.50mm x 20mm maverick 2 balloon catheter was advanced for dilation.The balloon was inflated, with resistance encountered, to 6 atmospheres for 2 seconds during the procedure but experienced poor retraction during deflation.Despite efforts to deflate the balloon for 5 seconds, it failed to retract properly, necessitating the removal of the original balloon.The device was removed along the guidewire and the procedure was completed with a different device.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
E1: initial reporter information: (b)(6).
Event or Problem Description
It was reported that balloon deflation issues occurred.The target lesion, which was 100% stenosed, was located in the moderately tortuous and mildly calcified right coronary artery (rca).A 6f guide catheter was utilized and a 2.50mm x 20mm maverick 2 balloon catheter was advanced for dilation.The balloon was inflated, with resistance encountered, to 6 atmospheres for 2 seconds during the procedure but experienced poor retraction during deflation.Despite efforts to deflate the balloon for 5 seconds, it failed to retract properly, necessitating the removal of the original balloon.The device was removed along the guidewire and the procedure was completed with a different device.No patient complications were reported as a result of this event.It was further reported the balloon deflated slowly without fully retracting and slight resistance was encountered upon removal of the balloon.
Additional Manufacturer Narrative
(b)(6).

• Brand Name: MAVERICK
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20193055
• Report Number: 2124215-2024-55482
• Device Sequence Number: 15173534
• Product Code: LOX
• UDI-Device Identifier: 08714729370185
• UDI-Public: 08714729370185
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

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: 09/10/2026
• Device Model Number: 7590
• Device Catalogue Number: 7590
• Device Lot Number: 0032394692
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 09/25/2024
• Date Device Manufactured: 09/11/2023
• 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: 43 YR
• Patient Sex: Male