MAUDE Adverse Event Report: BOSTON SCIENTIFIC DIREX STEERABLE SHEATH; CATHETER, ELECTRODE RECORDING OR PROBE

Lot Number C8-12613

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 05/09/2018

Event Type  malfunction  

Event Description

During an electrophysiologic study, a deflectable decapolar catheter lost the ability to deflect.Another catheter was then placed and procedure continued.

• Brand Name: DIREX STEERABLE SHEATH
• Type of Device: CATHETER, ELECTRODE RECORDING OR PROBE
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 7525412
• MDR Text Key: 108741545
• Report Number: MW5077293
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/16/2018

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 Lot Number: C8-12613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1