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

Model Number H7492062012200

Device Problems Leak/Splash (1354); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 06/01/2017

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: (b)(6).(b)(4).Device evaluated by mfr: the returned product consisted of a maverick otw balloon catheter and no other devices.The device was loosely folded.The hub/manifold, outer/inner shaft, and strain relief were microscopically and tactile inspected.Inspection revealed damage (cut) to the outer shaft, 9 mm from the distal end of the hub/manifold.Functional testing was performed by attaching an inflation device and drawing negative pressure, and air was coming back into the syringe.The inflation device was filled up with water, and positive pressure was applied, and water was found to be leaking from under the strain relief.When the strain relief was moved, damage (cut) was found on the outer shaft.Inspection of the remainder of the device found no other damage or irregularities.Further review of the manufacturing records for batch 20511346 will be performed.The root cause has been determined to be manufacturing related.(b)(4).

Event Description

Reportable based on device analysis completed on 12-jul-2017.It was reported that hub leakage occurred.During preparation of a 12 mm 2.00 maverick balloon catheter, it was noted that a lot of air kept getting back into the syringe.The stopcocks and the syringe were switched out however the same issue was encountered.The device was not used and the procedure was completed with a different device.No patient complications were reported.When the case was done, the balloon was re-inflated and it was noted that the actual manifold was leaking.However, returned device analysis revealed a shaft hole/perforation.

• Brand Name: MAVERICK
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6741076
• MDR Text Key: 80948164
• Report Number: 2134265-2017-07427
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729260288
• UDI-Public: (01)08714729260288(17)20200430(10)20511346
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: H7492062012200
• Device Catalogue Number: 20620-1220
• Device Lot Number: 20511346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1