MAUDE Adverse Event Report: COOK INC WIRE, GUIDE, CATHETER

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Internal Organ Perforation (1987)

Event Type  Injury  

Event Description

As reported in the literature by smith, rochon, & ray (2012), a 32-year-old female underwent urgent percutaneous nephrostomy placement upon presentation to the emergency department with fever and tenderness at the costovertebral angle.A ct scan noted a five-millimeter stone in the ureteropelvic junction and mild proximal hydronephrosis.The patient¿s white blood cell count was elevated at 46.1.The patient was tachycardic with a heart rate in the 140¿s.The patient was given a five-liter bolus of normal saline.A urinalysis noted many bacteria, nitrites, and positive leukocyte esterase.The patient was started on antibiotics (ceftriaxone and levofloxacin) and admitted to the intensive care unit (icu) prior to the procedure.The patient was intubated for the percutaneous nephrostomy placement, and hemodynamic support was provided by anesthesia.The patient was placed in a prone position and ultrasound guidance was used to place a cook chiba 21-gauge needle in the posterior calyx.Contrast was used to confirm placement, and a 0.018-inch wire was placed, followed by another manufacturer¿s dilator.The 0.018-inch wire was exchanged for an unspecified cook amplatz wire guide.The tract was dilated to 8-french, and an 8 french nephrostomy tube was placed.A diagnostic nephrostogram was performed, the tube was sutured to the skin, and the bag was placed to gravity drainage.The patient was transferred to the icu for monitoring and a diagnosis of urosepsis.The patient had 1875-milliliters of urine output in the first 24 hours and five-milliliters of urine output via the nephrostomy tube.Another nephrostogram was performed and the tube was upsized to 10-french.The nephrostogram was suggestive of a thrombus in the collecting system.Urine output through the tube did not increase over the next 24 hours.A ct kub was performed, noting that the nephrostomy tube had completely traversed the kidney.The pigtail was ventral to the renal cortex, coiling in the abdominal fat anterior to the kidney.The physician attempted to salvage the original tract in interventional radiology; however, was unsuccessful.The collecting system was accessed using ultrasound guidance and a new tube was placed in the renal pelvis.The new tube drained 1475-milliliters of urine in the next 24 hours.The stone and nephrostomy tube were removed twenty days later.The authors discuss that catheter malposition is a rare complication, and in this case, the authors conclude that two potential mechanisms could account for catheter malposition.The first possibility is that the other manufacturer¿s dilator system might have been advanced through the urothelium and then the cook amplatz wire may have passed through the same tract prior to placement of the nephrostomy tube.The second possibility, per the authors, is that the urothelium could have been punctured by the amplatz wire at the floppy-to-stiff transition point of the wire, as the urothelium was ill-defined and some contrast surrounded the kidney.There has been no alleged malfunction of the cook amplatz wire guide.Reference for article: smith, m., rochon, p.J., & ray, c.E.(2012).Traversing the renal pelvis during percutaneous nephrostomy tube placement (¿kidney kabob¿).Seminars in interventional radiology, 29(2).Http://dx.Doi.Org/ 10.1055/s-0032-1312578.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Common name & product code = unavailable as the device lot number, rpn, and gpn are unknown.Pma/510(k) number = unavailable as the device lot number, rpn, and gpn are unknown.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: WIRE, GUIDE, CATHETER
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC.; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 16241768
• MDR Text Key: 308493928
• Report Number: 1820334-2023-00062
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ACCUSTICK DILATOR-BOSTON SCIENTIFIC
• Patient Outcome(s): Other
• Patient Age: 32 YR
• Patient Sex: Female