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

Model Number	7580
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years of age or older.
Event or Problem Description
It was reported the shaft broke.A 2.50mm x 12mm maverick 2 mr balloon catheter was advanced for dilation.However, when the physician attempted to push the balloon inside the guide catheter, the mid section of the hypotube broke.The procedure was completed with a different device.No patient complications nor injuries were reported.
Additional Manufacturer Narrative
Age at time of event: 18 years of age or older.Device evaluated by mfr: the outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks along the hypotube.The hypotube is separated 71.6cm from the hub.The balloon is still tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported the shaft broke.A 2.50mm x 12mm maverick 2 mr balloon catheter was advanced for dilation.However, when the physician attempted to push the balloon inside the guide catheter, the mid section of the hypotube broke.The procedure was completed with a different device.No patient complications nor injuries were reported.

• 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: 8258626
• Report Number: 2134265-2019-00130
• Device Sequence Number: 11220814
• Product Code: LOX
• UDI-Device Identifier: 08714729369981
• UDI-Public: 08714729369981
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P860019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2019

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: 05/07/2021
• Device Model Number: 7580
• Device Catalogue Number: 7580
• Device Lot Number: 0022092034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Initial Date Received by Manufacturer: 12/27/2018
• Supplement Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 01/17/2019
• Supplement Report FDA Received Date: 02/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1