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

Model Number	7590
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: the device fg maverick 2 mr, 1.50mm x 20mm, stent delivery system was returned to the complaint investigation site.Visual, tactile and microscopic and leakage testing analysis was performed on the device.A visual and tactile examination identified multiple hypotube kinks along the length of the hypotube shaft and no issues identified with the outer / mid-shaft sections or the inner lumen of the device.Balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Bumper tip showed no signs of distal tip damage.During leakage testing, the device was attached to an encore inflation unit.A pinhole was located in the mid-section of the balloon when inflating to rated burst pressure of 20 atmospheres.The encore device was verified before and after use using the druck gauge.No other device issues were identified during returned product analysis.
Event or Problem Description
Reportable based on device analysis completed on 31jul2024.It was reported that crossing difficulties were encountered.The 75% stenosed target lesion was located in a severely tortuous and severely calcified lesion in the left anterior descending artery.A 1.50mm x 20mm maverick was advanced for treatment but could not pass through the lesion.The procedure was completed with a different device without any patient complications reported and the patient's status was fine.However, returned device analysis revealed a balloon longitudinal tear.

• 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: 20019000
• Report Number: 2124215-2024-52002
• Device Sequence Number: 12631641
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/20/2024

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: 09/04/2026
• Device Model Number: 7590
• Device Catalogue Number: 7590
• Device Lot Number: 0032359680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2023
• 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: 67 YR
• Patient Sex: Male