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	02/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the severely calcified left anterior descending artery.A 1.50mm x 15mm maverick balloon catheter was advanced for dilatation.However, during the procedure, the balloon ruptured.The procedure was completed with another of the same device.No patient complications nor injuries were reported, and the patient was in good condition post-procedure.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the severely calcified left anterior descending artery.A 1.50mm x 15mm maverick balloon catheter was advanced for dilatation.However, during the procedure, the balloon ruptured.The procedure was completed with another of the same device.No patient complications nor injuries were reported, and the patient was in good condition post-procedure.It was further reported that the target lesion was severely tortuous with 90% stenosis.It was noted that the balloon ruptured during the fifth inflation at 15 atmospheres for 30 seconds.
Additional Manufacturer Narrative
B5 - describe event or problem: updated to include new information obtained.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the severely calcified left anterior descending artery.A 1.50mm x 15mm maverick balloon catheter was advanced for dilatation.However, during the procedure, the balloon ruptured.The procedure was completed with another of the same device.No patient complications nor injuries were reported, and the patient was in good condition post-procedure.It was further reported that the target lesion was severely tortuous with 90% stenosis.It was noted that the balloon ruptured during the fifth inflation at 15 atmospheres for 30 seconds.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a maverick 2mr balloon catheter.A visual inspection revealed no damage or irregularity.A microscopic inspection revealed no further damage or irregularity.There was contrast in the inflation lumen and the loosely folded balloon.The device was prepped with an inflation device filled with water and connected to the calibrated pressure gage to inflate the device.The device inflated to rated burst pressure and deflated with no issue.

• 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: 18832509
• Report Number: 2124215-2024-12468
• Device Sequence Number: 12616324
• 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,Followup
• Report Date (Section B): 04/26/2024

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: 06/13/2026
• Device Model Number: 7585
• Device Catalogue Number: 7585
• Device Lot Number: 0031807380
• 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: 02/27/2024
• Supplement Date Received by Manufacturer: Not provided; 04/23/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 04/04/2024; 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2023
• 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: 72 YR
• Patient Sex: Female