MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE MAVERICK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	H7492062020150
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: returned product consisted of a maverick balloon catheter with an unidentified guidwire.The balloon was tightly folded.There was contrast in the inflation lumen.The outer shaft, inner shaft, balloon and tip were microscopically examined.The shaft was completely separated 26 cm from the hub and 112.5cm from the tip.A portion of the separated shaft, measured at 0.5cm, was still attached to the guide wire.The fracture faces were oval as if kinked prior to separation.There were numerous shaft kinks.There was no evidence of any material or manufacturing deficiencies contributing to the damage and the reported difficulty.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
Event or Problem Description
It was reported that shaft break and balloon detachment occurred.The target lesion was located in the ramus artery.A 20mm 1.50 maverick balloon catheter was advanced to dilate the lesion.However, after inflating the device, it was noted that the radiopaque marker was drifting ahead and they thought the balloon moved forward.The balloon was deflated and recaptured inside the guide catheter.The shaft was broken into multiple pieces.The entire guide catheter, guidewire and balloon catheter were removed and the procedure was completed with another maverick balloon catheter.No further patient complications were reported and the patient's status was fine.

• Brand Name: MAVERICK
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• MDR Report Key: 6504714
• Report Number: 2134265-2017-03604
• Device Sequence Number: 797235
• Product Code: LOX
• UDI-Device Identifier: 08714729224433
• UDI-Public: (01)08714729224433(17)20191031(10)19901485
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P860019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: H7492062020150
• Device Catalogue Number: 20620-2015
• Device Lot Number: 19901485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2017
• Initial Report FDA Received Date: 04/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention