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 Consequences Or Impact To Patient (2199)
Date of Event	05/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a coronary vessel.A 2.50 mm x 12 mm maverick 2 balloon catheter was advanced for dilatation.However, the delivery shaft was fractured.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
The device was returned for analysis.There was a hypotube separation 48.1cm distal of the strain relief.The hypotube fracture surface of the hypotube separation was ovaled indicating the hypotube was kinked prior to separation.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a coronary vessel.A 2.50mmx12mm maverick 2 balloon catheter was advanced for dilatation.However, the delivery shaft was fractured.The procedure was completed with another of the same device.There were no patient complications reported.It was further reported that the device was removed intact from the patient's body and was removed by the physician directly.

• 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: 8701179
• Report Number: 2134265-2019-06202
• Device Sequence Number: 2308361
• Product Code: LOX
• UDI-Device Identifier: 08714729369981
• UDI-Public: 08714729369981
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 07/15/2019

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: 11/28/2021
• Device Model Number: 7580
• Device Catalogue Number: 7580
• Device Lot Number: 0023004091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Initial Date Received by Manufacturer: 05/23/2019
• Supplement Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 06/14/2019
• Supplement Report FDA Received Date: 07/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 78