MAUDE Adverse Event Report: COVIDIEN LLC COVIDIEN PALINDROME HSI HEPARINSILVER ION CATHETER; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number REF 8888145049

Device Problem Break (1069)

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

Event Date 01/18/2020

Event Type  malfunction  

Event Description

Patient with esrd with dysfunctional left jugular tunneled catheter.Patient having replacement of left jugular tunneled catheter over a wire.When the surgeon was exchanging the blue sheath that goes into the center of the lumen it broke when the surgeon tried removing it.All pieces were removed and accounted for.After third attempt a new catheter was inserted without incident.Post op chest xray ordered and showed dialysis catheter tip projects over junction superior vena cava and right atrium.No pneumothorax.Fda safety report id # (b)(4).

• Brand Name: COVIDIEN PALINDROME HSI HEPARINSILVER ION CATHETER
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN LLC
• MDR Report Key: 9622080
• MDR Text Key: 176305049
• Report Number: MW5092432
• Device Sequence Number: 1
• Product Code: MSD
• 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: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REF 8888145049
• Device Lot Number: 1818500187
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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
• Patient Age: 69 YR
• Patient Weight: 300