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

Model Number	7590
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that the incorrect length of the balloon occurred.The patient underwent intravascular dilation with a balloon during coronary artery stent implantation.The 70% stenosed target lesion was located in a mildly tortuous and mildly to moderately calcified vessel.A 2.00mm x 20mm maverick balloon catheter was advanced for dilatation.The metal marker on the inner wall of the balloon measured 20 mm, which the physician used to measure the length of the diseased vessel.Based on this measurement, a 3.00 x 16 mm promus premier stent was selected for implantation.However, during implantation of the stent, it was noted that the stent could not fully cover the lesion.Upon releasing and withdrawing the stent, it was suspected that the length of the 2.00 mm x 20mm maverick balloon was shorter than 20mm.Then, the physician used the balloon within the released 3.00 x 16 mm promus premier stent to compare the markers of a 2.00 mm x 20mm maverick balloon, markers of a 2.00 mm x 20mm maverick balloon and 3.00 x 16 mm promus premier stent are the same length.Therefore, the physician believed that the 2.00 mm x 20mm maverick balloon length was shorter than 20mm and only 16mm long.A 2.00mm x 20mm non-boston scientific balloon was used to compare with the 2.00 mm x 20mm maverick balloon catheter and there was no difference in size, indicating that there was no problem with the balloon size.The procedure continued smoothly with the replacement of the balloon catheter with the appropriate size.

• 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: 20422393
• Report Number: 2124215-2024-61342
• Device Sequence Number: 8420404
• Product Code: LOX
• UDI-Device Identifier: 08714729370161
• UDI-Public: 08714729370161
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7590
• Device Catalogue Number: 7590
• Device Lot Number: 0033710857
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 10/10/2024
• Date Device Manufactured: 03/27/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR
• Patient Sex: Male