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

Model Number	7590
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2023
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 moderately tortuous and severely calcified left anterior descending artery.A 1.50mm x 20mm maverick balloon catheter was advanced for dilatation.Inflation was performed three times.However, during the third inflation at 6 atmospheres, the balloon burst.The procedure was completed with another of same device.There were no patient complications reported, and the patient condition was stable post-procedure.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 1.50mm x 20mm maverick balloon catheter was advanced for dilatation.Inflation was performed three times.However, during the third inflation at 6 atmospheres, the balloon burst.The procedure was completed with another of same device.There were no patient complications reported, and the patient condition was stable post-procedure.It was further reported that the device was completely removed, and it did not detach inside the patient's body.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a maverick 2mr balloon catheter.The device was visually and microscopically examined.There was blood and contrast in the inflation lumen and the balloon.The balloon was loosely folded.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There was a pinhole in the balloon located at the proximal end of the distal markerband.The device failed to inflate to rbp.Product analysis confirmed the reported event, as during functional testing the device was found to have a pinhole damage to the balloon.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 1.50mm x 20mm maverick balloon catheter was advanced for dilatation.Inflation was performed three times.However, during the third inflation at 6 atmospheres, the balloon burst.The procedure was completed with another of same device.There were no patient complications reported, and the patient condition was stable post-procedure.It was further reported that the device was completely removed, and it did not detach inside the patient's body.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16587292
• Report Number: 2124215-2023-13104
• Device Sequence Number: 20064956
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/15/2023

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: 01/04/2026
• Device Model Number: 7590
• Device Catalogue Number: 7590
• Device Lot Number: 0030792133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/17/2023
• Supplement Date Received by Manufacturer: 03/26/2023; 05/04/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 03/28/2023; 05/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2023
• 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: 85 YR
• Patient Sex: Male