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

Model Number	7590
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of the maverick 2 balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast in the inflation lumen and balloon.The balloon was loosely folded.Inspection of the device revealed numerous kinks throughout the hypotube and a complete hypotube separation 76cm distal of the strain relief.An inflation device filled with water was connected to the remaining distal end of the device by attaching a toughy and a stopcock to the end of the separated hypotube.When positive pressure was applied, the balloon was able to be inflated immediately with no leaks or issues.Product analysis did not confirm the reported event, as the balloon was loosely folded indicating that it was able to be inflated at the facility and during functional testing the balloon inflated to rated burst pressure with no issues immediately.
Event or Problem Description
Reportable based on device analysis completed on 14-jan-2021.It was reported that balloon inflation failure occurred.During preparation, a 1.50 mm x 20 mm maverick balloon catheter was selected for dilatation.However, the balloon failed to inflate.The procedure was completed with another of same device.No patient complications were reported and the patient status was stable.However, returned device analysis revealed hypotube separation.It was further reported that the break occurred outside the patient's body.

• Brand Name: MAVERICK
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11261150
• Report Number: 2134265-2021-00549
• Device Sequence Number: 16322325
• Product Code: LOX
• UDI-Device Identifier: 08714729370154
• UDI-Public: 08714729370154
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/01/2021

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: 07/16/2022
• Device Model Number: 7590
• Device Catalogue Number: 7590
• Device Lot Number: 0024119911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 02/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 75