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

Model Number M0042011020

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer: visual inspection of the device observed that the shipping tube had been bent in two places at approximately 31cm and 78.5cm from the distal end.Also, cracked was noted where the two bends located and had deformed the insulation of the shaft in these two locations.The wire braid of the outer insulation is visible at the bend that is approximately 31cm from the distal end.The initial inspection, which is performed prior to decontamination has the following observations: ¿kink by tip and handle.Catheter returned in plastic tube/sleeve¿.The observations indicate that the damage to the shaft insulation from the cracked shipping sleeve most likely occurred during the sterilization process after the device was returned.Also, a bend was noted in the distal shaft located at approximately 6.2cm from the distal end which is proximal to e10.The bend by the handle is located at approximately 106.5cm from the distal end and aligns where the shipping tube ended on the device shaft.The insulation is cut in this location and the wire braid of the outer insulation is exposed and the guide coil and electrode wires are visible.The electrode footprints are aligned on the outside curve as expected and there are dried body fluids on the connector and shaft.Functional inspection was performed and observed that the push/pull knob and thumbwheel functioned properly and there was no abnormal resistance felt when actuating the steering mechanism.Dimensional inspection was performed and the tip motion was evaluated against a ruler.The curve failed as it did not reach between 3 and 4.5cm.X-rays revealed that the flat wire is bent in three areas in the distal end and is making contact with the distal tip.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).

Event Description

Reportable based on device analysis completed on 25-jan-2018.It was reported that the device had difficulty reaching target lesion.The target lesion was located in the supraventricular artery.A dynamic xt¿ unidirectional steerable diagnostic catheter was selected for use.During procedure, it was noted that the device could not reach the target position.The procedure was completed with another of the same device.No patient complications were reported and patient 's status was stable.However, device analysis revealed that the wire braid of the outer insulation is visible at the bend 31cm from the distal end.

• 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: 7281846
• MDR Text Key: 100543678
• Report Number: 2134265-2018-01116
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: CN
• 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: 01/25/2018

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: 05/23/2020
• Device Model Number: M0042011020
• Device Catalogue Number: 201102
• Device Lot Number: 20686692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2018
• Initial Date FDA Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2017
• 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