MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. PENTARAY NAV; CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY

Model Number D128211

Device Problem Material Twisted/Bent (2981)

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

Event Date 05/19/2020

Event Type  malfunction  

Event Description

The pentaray catheter (used for ablation mapping) end became bent after brief use and needed to be replaced with a new pentaray.The procedure was completed without complications.

• Brand Name: PENTARAY NAV
• Type of Device: CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 15715 arrow hwy; irwindale CA 91706
• MDR Report Key: 10350371
• MDR Text Key: 201215894
• Report Number: 10350371
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: (01)10846835012255(17)230224(10)30365503L
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/29/2020

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 Model Number: D128211
• Device Catalogue Number: D128211
• Device Lot Number: 30365503L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/29/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/31/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18615 DA
• Patient Weight: 68