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

Model Number	7590
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break occurred, requiring additional intervention.The patient presented with coronary heart disease and underwent coronary angioplasty.The 90% stenosed target lesion was moderately tortuous and severely calcified.A 2.00mm x 20mm maverick balloon catheter was advanced for dilatation.The balloon was deflated, and a little resistance was felt when removing the device.However, the distal portion which was 30 centimeters of the balloon that connects to the hypotube was detached.The fractured part of the device was trapped with another coronary balloon.A 2.0 x 20 emerge balloon catheter was then used to complete the procedure.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: fg maverick 2 mr, 2.00mm x 20mm, was returned for analysis.Visual, tactile and microscopic analysis was performed on the device.A visual inspection of the outer and inner lumen and tactile examination of the entire extrusion found a break 58cm from the distal tip and multiple instances of stretching and kinking throughout the shaft.The hypotube and manifold of the device was not returned.The balloon had a complete circumferential tear approximately 7mm from the proximal edge of the balloon sleeve, the distal section of the balloon tear was pulled over the distal bumper tip however no sections of the balloon had detached.A microscopic examination of the bumper tip showed no signs of distal tip damage.
Event or Problem Description
It was reported that shaft break occurred, requiring additional intervention.The patient presented with coronary heart disease and underwent coronary angioplasty.The 90% stenosed target lesion was moderately tortuous and severely calcified.A 2.00mm x 20mm maverick balloon catheter was advanced for dilatation.The balloon was deflated, and a little resistance was felt when removing the device.However, the distal portion which was 30 centimeters of the balloon that connects to the hypotube was detached.The fractured part of the device was trapped with another coronary balloon.A 2.0 x 20 emerge balloon catheter was then used to complete the procedure.No patient complications were reported.

• 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 ; MY 14110
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19627054
• Report Number: 2124215-2024-37594
• Device Sequence Number: 8084636
• Product Code: LOX
• UDI-Device Identifier: 08714729370161
• UDI-Public: 08714729370161
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/19/2026
• Device Model Number: 7590
• Device Catalogue Number: 7590
• Device Lot Number: 0031852531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Supplement Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female