MAUDE Adverse Event Report: BIOSENSE WEBSTER; ABLATION CATHETER

Catalog Number BN175TCDDH

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/17/2015

Event Type  malfunction  

Event Description

When the ablation catheter was pulled back for removal from the venous system, it became stuck in the sheath, which assumed a j shape.The flexion mechanism on the catheter appeared to be broken.

• Type of Device: ABLATION CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER; ft worth TX 76134
• MDR Report Key: 5327193
• MDR Text Key: 34437539
• Report Number: MW5058726
• Device Sequence Number: 1
• Product Code: LPB
• 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: 12/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: BN175TCDDH
• Device Lot Number: 17148261N
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR