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	08/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending artery.A 2.00mm x 20mm maverick balloon catheter was selected for use.However, after inserting the balloon for treatment on the lesion, the balloon ruptured at 6 atmospheres during inflation.The lesion was somewhat calcified and the procedure was completed with another 2.0 x 20mm maverick balloon catheter.There were no patient complications reported.Patient was in good condition.
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending artery.A 2.00mm x 20mm maverick balloon catheter was selected for use.However, after inserting the balloon for treatment on the lesion, the balloon ruptured at 6 atmospheres during inflation.The lesion was somewhat calcified and the procedure was completed with another 2.0 x 20mm maverick balloon catheter.There were no patient complications reported.Patient was in good condition.
Additional Manufacturer Narrative
Device evaluated by mfr: fg maverick 2 mr, 2.00mm x 20mm was returned for analysis.Visual / tactile inspection revealed that the balloon contained blood and was returned in a deflated state.No issues or damages on the hypotube shaft profile.A detailed microscopic examination of the balloon material identified a pinhole 1mm proximal from the distal markerband.No issues or damages on the tip profile.A microscopic examination of the markerband identified no damage.The device was attached to an encore inflation device.An attempt was made to inflate the balloon however a pinhole was located 1mm proximal from the distal markerband.The encore device verified before and after use using the druck gauge.

• 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: 20183775
• Report Number: 2124215-2024-56383
• Device Sequence Number: 8298549
• Product Code: LOX
• UDI-Device Identifier: 08714729370161
• UDI-Public: 08714729370161
• 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): 11/21/2024

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: 7590
• Device Catalogue Number: 7590
• Device Lot Number: 0034285943
• 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: 08/30/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2024
• 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: 79 YR
• Patient Sex: Male