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

Model Number	86708
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.Visual inspection showed dried body fluid on the shaft.There was a gouge in the distal end shaft with a piece of the shaft material lifted and attached on one side.The lifted shaft material was securely attached.The gouge was located approximately 7mm from the distal tip which was between ring 1 and ring2.The electrode footprints were aligned on the outside curve as expected, however e9 and e10 are marginally within the limits.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 using a multimeter with the following results: electrode 5 and electrode 6 were shorted together.No opens were present.X-rays showed that the flat wire is not in contact with the distal electrode.The distal end was dissected at the proximal end of the flat wire.Both the e5 and e6 signal wires have damage that was consistent with rubbing against the edge of the flat wire.The flat wire insulation was missing in the same locations as the wire damages.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
Event or Problem Description
Reportable based on device analysis completed on 13sep2019.During an ablation procedure with a dynamic xt, the carto was making a lot of noise.The catheter was replaced and the replacement was used successfully.No patient complications occurred.However, device analysis revealed a gouge in the distal end shaft with a piece of shaft material lifted but securely attached to the device.

• Brand Name: DYNAMIC XT
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 9161840
• Report Number: 2134265-2019-12082
• Device Sequence Number: 2151901
• Product Code: DRF
• UDI-Device Identifier: 08714729877653
• UDI-Public: 08714729877653
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K921872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/07/2019

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: 05/16/2022
• Device Model Number: 86708
• Device Catalogue Number: 86708
• Device Lot Number: 0023810774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 10/07/2019
• Patient Sequence Number: 1