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 Problems Electrical /Electronic Property Problem (1198); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a curvature and electrode issue occurred.A 6f 110cm dynamic xt unidirectional steerable diagnostic catheter was selected use.During the procedure, a unspecified problem of curvature and electrode occurred.A risk for tissue injury was noted.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.A visual inspection was performed and the device does not have visual defects.Functional inspection of the steering knob functioned properly.The curve are placed in the template shaded areas the device passed the dimensional test.The catheter connector mated to the test cable with no issues noted on the electrodes during an electrical test.No issues on the electrodes.The device passed the electrical tests.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).

Event Description

It was reported that a curvature and electrode issue occurred.A 6f 110cm dynamic xt(tm) unidirectional steerable diagnostic catheter was selected use.During the procedure, a unspecified problem of curvature and electrode occurred.A risk for tissue injury was noted.No patient complications were reported.

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5851095
• MDR Text Key: 51294618
• Report Number: 2134265-2016-07317
• 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,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/12/2016

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: 04/19/2019
• Device Model Number: M0042011010
• Device Catalogue Number: 201101
• Device Lot Number: 19164673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2016
• Initial Date FDA Received: 08/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2016
• 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: 64 YR