MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) DYNAMIC XT¿ UNIDIRECTIONAL STEERABLE DIAGNOSTIC CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number M0042011010

Device Problem Device Sensing Problem (2917)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device was returned for analysis.Visual inspection revealed the electrode footprints are not aligned in the center of the outward curve as expected.Electrodes 1-4 are aligned in the center of the outward curve but the rest of the rings migrate to the side of the curve.Electrodes 7 and 8 are located on the edge of the curve and electrodes 9 and 10 are located on the inside of the curve.An electrical test was performed on all electrodes with a multimeter, an intermittent resistive short between the distal tip and e8 was present in the curve position; no opens were present.Functional inspection revealed that inspection shows that the push/pull knob functioned properly.No abnormal resistance was felt when actuating the steering mechanism.Dimensional inspection revealed that tip motion was evaluated against a ruler.The curve failed; the curve does not reach between 3 and 4.5cm.The curve is out of plane.X-rays revealed that the flat wire is making contact with the distal electrode.The distal end was dissected.There is dried blood in the interior of the sheath that is heavy near the tip and tapers out at approximately 6cm from the distal end.There is some evidence of adhesive between the insulation sheath and the distal electrode however the adhesive is not continuous.The insulation was easily lifted from the distal electrode.All electrodes were lifted; there was no evidence of body fluid under any of them.The flat wire is not attached to the polymide.The polymide is not attached to the inner insulation.All the electrode footprints align with the holes in the insulation.Some of the wires are twisted around the flat wire.Electrode 8 wire has compromised insulation and there are gouges on the exposed wire that are consistent with marks made by the edge of the flat wire.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is manufacturing process design as the design or validation of the manufacturing process was not sufficient to ensure the finished device met the intent of the design.(b)(4).

Event Description

Reportable based on device analysis completed on 20-april-2018.It was reported that the electrodes were broken.A 6f,110cm, lrgcrv,10e, 2, 5, 2mm dynamic xt¿ unidirectional steerable diagnostic catheter was selected for use.During the procedure, it was noted that electrodes 1-2-7-8-9-10 were broken on the decapolar catheter.Cable were changed but still there was no signal detected.The procedure was completed with another with the same device.No patient complications were reported.However, returned device analysis revealed a body fluid ingress.

• Brand Name: DYNAMIC XT¿ UNIDIRECTIONAL STEERABLE DIAGNOSTIC CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7498269
• MDR Text Key: 107720597
• Report Number: 2134265-2018-04094
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K921872A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/20/2018

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: 10/16/2020
• Device Model Number: M0042011010
• Device Catalogue Number: 201101
• Device Lot Number: 21267514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2018
• Initial Date FDA Received: 05/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2017
• 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
• Patient Age: 57 YR