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

Model Number	7590
Medical Device Problem Codes	Material Rupture (1546); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 1.50mm x 20mm maverick balloon catheter was advanced for dilatation.However, the device failed to cross the lesion, and when the balloon was inflated at nominal pressure, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications nor injuries reported, and the patient condition was good post-procedure.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 1.50mm x 20mm maverick balloon catheter was advanced for dilatation.However, the device failed to cross the lesion, and when the balloon was inflated at nominal pressure, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications nor injuries reported, and the patient condition was good post-procedure.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a maverick 2mr balloon catheter.Visual inspection revealed no damage or irregularity.Microscope inspection revealed a pinhole at the proximal end of the markerband.There was blood and contrast in the inflation lumen and the loosely folded balloon.Product analysis confirmed the reported event, as the device was found to have a pinhole to the balloon.Analysis could not confirm the reported crossing difficulties, which could not be confirmed because the clinical circumstances could not be replicated.

• 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: 18401295
• Report Number: 2124215-2023-73975
• Device Sequence Number: 14146538
• 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): 02/28/2024

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: 06/19/2026
• Device Model Number: 7590
• Device Catalogue Number: 7590
• Device Lot Number: 0031852523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2023
• Supplement Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 02/28/2024
• 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
• Patient Age: 57 YR
• Patient Sex: Female