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	08/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 90% stenosed target lesion was located in the severely tortuous and severely calcified left circumflex artery.A 1.50mm x 15mm maverick balloon catheter was advanced for dilatation.However, upon inflation, the balloon ruptured.The procedure was completed with another of the same device.There was no patient complications reported, and patient was in good condition post-procedure.
Event or Problem Description
It was reported that balloon rupture occurred.A 90% stenosed target lesion was located in the severely tortuous and severely calcified left circumflex artery.A 1.50mm x 15mm maverick balloon catheter was advanced for dilatation.However, upon inflation, the balloon ruptured.The procedure was completed with another of the same device.There was no patient complications reported, and patient was in good condition post-procedure.
Additional Manufacturer Narrative
Device evaluated by mfr.: the fg maverick 2 mr, 1.50mm x 15mm catheter was returned for analysis.A visual, tactile, microscopic analysis, and leakage testing were performed on the device.The balloon was returned in a deflated state.No issues or damages on the hypotube shaft.A detailed microscopic examination of the balloon material identified a pinhole over the distal edge of the markerband.No issues or damages on the shaft polymer extrusion.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 noted over the distal edge of the markerband.The encore device verified before and after use using the druck gauge.No other device issues were identified during returned product analysis.

• 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: 19990271
• Report Number: 2124215-2024-50535
• Device Sequence Number: 7087390
• Product Code: LOX
• UDI-Device Identifier: 08714729370055
• UDI-Public: 08714729370055
• 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): 11/08/2024

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: 0033898637
• 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: 08/07/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2024
• 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