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

Model Number	7585
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending artery.A 2.50mm x 15mm maverick balloon catheter was advanced for dilation.However, during the procedure, the balloon ruptured at rated burst pressure due to heavy tight calcification.The device was removed and completed the procedure with another of the same device.There were no patient complications reported.Patient was in good condition.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending artery.A 2.50mm x 15mm maverick balloon catheter was advanced for dilation.However, during the procedure, the balloon ruptured at rated burst pressure due to heavy tight calcification.The device was removed and completed the procedure with another of the same device.There were no patient complications reported.Patient was in good condition.
Additional Manufacturer Narrative
Device evaluated by mfr.: fg maverick 2 mr, 2.50mm x 15mm was returned for analysis.Visual / tactile inspection identified multiple kinks along the hypotube.No kinks or damages.Microscopic analysis revealed no issues identified during a microscopic examination of the extrusion shaft.A detailed microscopic examination of the balloon material identified no damages.No tears or pinholes were observed in the balloon material.A microscopic examination of the tip section found no damage.Leakage test revealed that the device was attached to a pretested encore inflation unit (encore tested using a druck gauge).The balloon was inflated to its rated burst pressure (rbp) of 14atmospheres with no leaks noted.A vacuum was pulled and the balloon deflated without any issue.The balloon was inflated for three more occasions and on each occasion the balloon inflated to its rbp and maintained pressure with no leaks noted.

• 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: 19278010
• Report Number: 2124215-2024-28052
• Device Sequence Number: 6320262
• Product Code: LOX
• UDI-Device Identifier: 08714729370086
• UDI-Public: 08714729370086
• 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): 07/04/2024

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 Model Number: 7585
• Device Catalogue Number: 7585
• Device Lot Number: 0032926757
• 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: 05/03/2024
• Supplement Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 07/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2023
• 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