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

Model Number	7590
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6) hospital.E1: initial reporter phone: (b)(6).Device evaluated by mfr: returned product consisted of a maverick 2mr balloon catheter.A visual inspection revealed numerous kinks to the hypotube of the device.At 25.8cm from the strain relief, the hypotube was separated.Microscopic inspection revealed no damage or irregularity.There was contrast in the inflation lumen and the loosely folded balloon.The distal portion of the separation was prepped with a tuohy and an inflation device filled with water to inflate the device which was then attached to the calibrated pressure gage to inflate the device.The device inflated and deflated to rated burst pressure with no issue or irregularity.
Event or Problem Description
Reportable based on device analysis completed on 11-mar-2024.It was reported that balloon leak occurred.The target lesion is located in the right femoral artery.A 2.50mm x 20mm maverick balloon catheter was advanced for dilation.However, during inflation, it was found that the balloon was leaking gas and could not inflate normally.The procedure was completed with another of same device.There were no patient complications reported, and the patient condition was stable post-procedure.However, returned device analysis revealed hypotube break.

• 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: 18983419
• Report Number: 2124215-2024-17987
• Device Sequence Number: 2833189
• Product Code: LOX
• UDI-Device Identifier: 08714729370185
• UDI-Public: 08714729370185
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/26/2024

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: 05/17/2026
• Device Model Number: 7590
• Device Catalogue Number: 7590
• Device Lot Number: 0031641184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2023
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 55 KG