MAUDE Adverse Event Report: ANGIODYNAMICS ABCESSION CATHETER

Catalog Number 14000804

Device Problems Break (1069); Detachment Of Device Component (1104); Occlusion Within Device (1423)

Patient Problems Fever (1858); Incontinence (1928); Urinary Tract Infection (2120); Device Embedded In Tissue or Plaque (3165)

Event Date 08/25/2017

Event Type  Injury  

Event Description

Nephrostomy tube was placed in (b)(6)2017, pt went home and noted to have no urinary output at that time.Pt waited and then came to hospital on (b)(6) 2017.Pt was seen in er.Labs, ua, blood cx, urine cultures and ct of abd / pelvis was completed.Pt has bilateral nephrostomy tubes the rt side noted to have hydronephrosis on ct scan, their recommendation was to flush or reposition tube.Once removal of nephrostomy tube was completed, a part of the cap was noted to be retained in the hub of the nephrostomy tube, which had broken off the cap.The radiology specialist was able to push a guide wire through once the old nephrostomy tube was removed and noted the clear small plastic piece that was broken off in the hub of the tube.Following tube removal, pt had immediate urine output of the right side.Pt was admitted to the hospital with fever.Uti and malfunctioning nephrostomy tube.She then developed septic shock and ended up in icu on a levophed iv drip.

• Brand Name: ABCESSION CATHETER
• Type of Device: ABCESSION CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; NL
• MDR Report Key: 6848234
• MDR Text Key: 85370335
• Report Number: MW5071993
• Device Sequence Number: 1
• Product Code: GBX
• 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: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 14000804
• Device Lot Number: 4951855
• 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 Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 45 YR