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

Model Number D128211

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/22/2020

Event Type  malfunction  

Event Description

Prior to the procedure, it was discovered that the lumen of the pentaray catheter was occluded.The catheter did not go into the patient's body, and the procedure was carried out with a different pentaray catheter.There was no patient impact.

• 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: 10441700
• MDR Text Key: 204041090
• Report Number: 10441700
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: (01)10846835012255(17)230604(10)30398659L
• 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: 08/19/2020

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: 30398659L
• 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: 08/19/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/24/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27010 DA
• Patient Weight: 103