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

Model Number	7585
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: above 18 years and older.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 2.75mm x 15mm maverick balloon catheter was advanced for pre-dilatation.However, it was noted that the shaft broke inside the arch of the aorta.The device was removed and used another maverick 2.75mm x 15mm and completed the procedure.No patient complications were reported and the patient's status was stable.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 2.75mm x 15mm maverick balloon catheter was advanced for pre-dilatation.However, it was noted that the shaft broke inside the arch of the aorta.The device was removed and used another maverick 2.75mm x 15mm and completed the procedure.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
A2: age at time of event: above 18 years and older.Device evaluated by mfr: returned product consisted of a maverick2 balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast in the inflation lumen.The balloon was tightly folded.There were numerous hypotube kinks throughout the device.There was a complete hypotube separation 88cm distal of the strain relief.The hypotube fracture surfaces were ovaled, which suggests the device was kinked prior to separation.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 8663623
• Report Number: 2134265-2019-05772
• Device Sequence Number: 2182949
• Product Code: LOX
• UDI-Device Identifier: 08714729370093
• UDI-Public: 08714729370093
• 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): 07/18/2019

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: 11/20/2021
• Device Model Number: 7585
• Device Catalogue Number: 7585
• Device Lot Number: 0022971724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 06/03/2019
• Supplement Report FDA Received Date: 07/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1