MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAMIC XT; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number M0042011010

Device Problems Electrical /Electronic Property Problem (1198); Poor Quality Image (1408)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2018

Event Type  malfunction  

Event Description

Reportable based on analysis completed on (b)(6) 2019.It was reported that a dynamic xt electrode catheter was selected for a procedure.However during the procedure it was noticed that there was noise on the bipolar electrodes.However, returned device analysis revealed damage to catheter shaft.Visual examination of the device revealed that there is a scrape in the insulation starting from the distal end/proximal shaft transition that extends to the tip.At proximal side of each electrode a sliver of the insulation is raised where the scrape ends.In the area between the tip and electrode 2 there are two scrapes on opposite sides of the shaft.All insulation slivers appear to be anchored securely.The electrode footprints are not aligned in the center of the outward curve as expected.Electrodes 2-8 footprints are within the range but electrodes 9 and 10 are on the side of the curve.The curve was found to be out of plane.Inspection shows that the plunger slide functioned properly.No abnormal resistance was felt when actuating the steering mechanism.The catheter connector mated to the test cable with no issues.No electrical issues were found with this device in a straight or curve position; no opens or shorts were present.X-rays showed that the flat wire is twisted and not in contact with the distal electrode.The outer diameter of the distal end is within specifications.The distal end was dissected.There is insulation and wire damage to e10 near the electrode that is consistent with the wire rubbing against the edge of the flat wire.There is corresponding damage to the insulation of the flat wire.

• Brand Name: DYNAMIC XT
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway; global park, la aurora,; heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330,; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 8369657
• MDR Text Key: 137135730
• Report Number: 2134265-2019-01707
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729877615
• UDI-Public: 08714729877615
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K921872
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/26/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2021
• Device Model Number: M0042011010
• Device Catalogue Number: 86706
• Device Lot Number: 0021624894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2019
• Initial Date FDA Received: 02/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1