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

Model Number	7585
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a shaft break occurred.The 80% stenosed target lesion was located in the calcified and moderately tortuous proximal ramus interventricularis anterior (riva).A 3.00 mm x 15 mm maverick 2 balloon was used to dilate the lesion.The maverick 2 was withdrawn into the guide catheter.After the maverick 2 was pulled out of the guide catheter, a broken shaft was noticed.The guide catheter, guidewire, and the broken maverick 2 were removed completely and the procedure was completed.No patient complications were reported in relation to this event.The device was returned for analysis.Returned product consisted of the hub and proximal hypotube of a maverick 2 balloon catheter.The distal portion of the hypotube, shaft, balloon and tip were not returned.The outer shaft, inner shaft, balloon and tip were microscopically examined.The hypotube was completely separated 74.5cm from the hub.The hypotube fracture surface was ovaled and torn, which suggests the device was kinked prior to separation.There are numerous hypotube kinks.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that a shaft break occurred.The 80% stenosed target lesion was located in the calcified and moderately tortuous proximal ramus interventricularis anterior (riva).A 3.00 mm x 15 mm maverick 2 balloon was used to dilate the lesion.The maverick 2 was withdrawn into the guide catheter.After the maverick 2 was pulled out of the guide catheter, a broken shaft was noticed.The guide catheter, guidewire, and the broken maverick 2 were removed completely and the procedure was completed.No patient complications were reported in relation to this event.Device evaluated by mfr: the device was returned for analysis: returned product consisted of the hub and proximal hypotube of a maverick 2 balloon catheter.The distal portion of the hypotube, shaft, balloon and tip were not returned.The hypotube was microscopically examined.The hypotube was completely separated 74.5cm from the hub.The hypotube fracture surface was ovaled and torn, which suggests the device was kinked prior to separation.There are numerous hypotube kinks.Inspection of the remainder of the device presented no other damage or irregularities.There was no evidence of any material or manufacturing deficiencies contributing to the damage and the reported event.
Additional Manufacturer Narrative
Correction: the statement: the outer shaft, inner shaft, balloon and tip were microscopically examined was removed from the analysis.Correction: added to method codes: analysis of production records.Added to evaluation results codes: deformation problem.

• 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: 8034432
• Report Number: 2134265-2018-62444
• Device Sequence Number: 1303269
• Product Code: LOX
• UDI-Device Identifier: 08714729370109
• UDI-Public: 08714729370109
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P860019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2019

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: 7585
• Device Catalogue Number: 7585
• Device Lot Number: 0022089100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Initial Date Received by Manufacturer: 10/09/2018
• Supplement Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 03/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR