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

Model Number M0042011010

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Information (3190)

Event Date 09/19/2018

Event Type  malfunction  

Event Description

Catheter was removed from packaging and noticed there was kink in the middle of the body of the catheter.Another catheter was used.

• Brand Name: DYNAMIC XT¿
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline ave n; saint paul MN 55112
• MDR Report Key: 7937901
• MDR Text Key: 122838576
• Report Number: 7937901
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/25/2018,09/19/2018

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: Other
• Device Model Number: M0042011010
• Device Catalogue Number: M0042011010
• Device Lot Number: 22449432
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/25/2018
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/05/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2018
• Type of Device Usage: N
• Patient Sequence Number: 1