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

Model Number	7590
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 85% stenosed target lesion was located in a severely tortuous and severely calcified left circumflex artery.A 1.50mm x 20mm maverick balloon catheter was advanced for dilation.However, during the procedure, the balloon burst.The device was removed from the patient's body and the procedure was completed with a different device without any patient complications.The patient was in good condition.
Additional Manufacturer Narrative
Device evaluated by mfr.: fg maverick 2 mr, 1.50mm x 20mm was returned for analysis.A visual, tactile, microscopic and leakage test was performed on the returned device.Visual and tactile inspection identified multiple hypotube kinks along the length of the shaft of the device.No issues identified with the distal extrusion.A pinhole was identified distal of the middle markerband, in the balloon.Tip showed no signs of tip damage.A microscopic examination of the markerband identified no damage.An encore inflation unit was used to inflate the balloon to 14 atmospheres.A microscopic examination and leakage test found the reported allegation, with a pinhole identified distal of the middle markerband, no other damages were observed along the device.
Event or Problem Description
It was reported that balloon rupture occurred.The 85% stenosed target lesion was located in a severely tortuous and severely calcified left circumflex artery.A 1.50mm x 20mm maverick balloon catheter was advanced for dilation.However, during the procedure, the balloon burst.The device was removed from the patient's body and the procedure was completed with a different device without any patient complications.The patient was in good condition.

• 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: 19656195
• Report Number: 2124215-2024-40658
• Device Sequence Number: 20481978
• Product Code: LOX
• UDI-Device Identifier: 08714729370154
• UDI-Public: 08714729370154
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2024

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: 08/07/2026
• Device Model Number: 7590
• Device Catalogue Number: 7590
• Device Lot Number: 0032167977
• 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: 06/18/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2023
• 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: 81 YR
• Patient Sex: Male