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 06/29/2018

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 29-jan-2019.It was reported that noise occurred on the bipolar electrodes.During an ablation procedure with a dynamic xt electrode catheter, noise occurred on the bipolar electrodes; the electrodes were faulty.No serious injury or adverse patient effects occurred.However, returned device analysis revealed catheter damage.The device was returned for analysis.Visual inspection found a scrape in the insulation starting from approximately 14cm from the tip that extends to the tip which includes both the proximal shaft and distal end.At proximal side of each electrode (including the tip) a sliver of the insulation was raised where the scrape ends.In the area between the tip and electrode 2 there were two scrapes on opposite sides of the shaft with raised slivers of insulation.All insulation slivers appeared to be anchored securely.The electrode footprints were not aligned in the center of the outward curve as expected.Electrodes 2-6 footprints were within the range of the welding inspection fixture but the others migrated to the side of the curve.The curve was misshaped and out-of-plane.Inspection showed that the plunger functioned properly.No abnormal resistance was felt when actuating the steering mechanism.The catheter connector mated to the test cable with no issues.An electrical test was performed on all electrodes with a multimeter with the following results: electrodes 3, 6 and 10 were shorted together in the curve position; no opens were present.X-rays showed that the flat wire is not in contact with the distal electrode.The outer diameter of the distal end is within specifications as measurement on the keyence.The distal end was dissected.There was insulation and wire damage to e10 near the electrode that was consistent with the wire rubbing against the edge of the flat wire.There was 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: 8349470
• MDR Text Key: 136500489
• Report Number: 2134265-2019-01406
• 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: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• 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
• Date Manufacturer Received: 01/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2018
• 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