MAUDE Adverse Event Report: COVIDIEN GOOSENECK SNARE; CATHETER, PERCUTANEOUS

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fistula (1862); Hematoma (1884); Injury (2348)

Event Date 04/21/2020

Event Type  Injury  

Manufacturer Narrative

Age or date of birth: average age, sex: majority gender, event date: date of article publication - event date is literature article published date.Journal article title: clinical utility of the modified snare technique for percutaneous antegrade removal of double j ureteral stents jvir (2020) 31:155-161 10.1016/j.Jvir.2019.04.026.If information is provided in the future, a supplemental report will be issued.

Event Description

This retrospective cohort study provides information on the common use of a snare device for antegrade double j (dj) stent removal.The author reports that there are some cases in which dj stent removal using only a snare is particularly difficult.In the present study, an unfavorable positioning of the proximal dj stent tip and tip embeddedness were significantly associated with a simple snare technique failure; thus, present the modified snare technique to overcome the simple snare technique failure.Under local anesthesia using lidocaine and fluoroscopic guidance, the 9f vascular sheath was exchanged for the previously inserted 8.5f percutaneous nephrostomy (pcn) tube.Using the simple snare technique, a snare amplatz goose neck snare with a diameter of 10 or 15 mm and a 6f snare-guiding catheter, was used to grasp the proximal dj stent tip.When the modified snare technique was used, after the vascular sheath was introduced into the renal pelvis via the guidewire, both the additional 0.035-inch guidewire and the snare-guiding catheter were inserted through the vascular sheath.A combination of snare and guidewire was used to grasp the dj stent.When the guidewire was caught with a snare, the snare-guiding catheter was withdrawn into the sheath.If the guidewire wound the dj stent, the whole assemblies, including the dj stent, guidewire, snare-guiding sheath as well as the vascular sheath, were removed to pull the dj stent out of the skin.If the guidewire failed to wind the dj stent, the guidewire was detached from the snare and catching the guidewire was repeated.For the patients who required repeated dj stent insertion, a dj stent was inserted through the guidewire in an antegrade direction.If repeated dj stent insertion was not necessary, the vascular sheath was removed or changed with an 8.5f pcn tube.In some patients whose proximal dj stent tip was not able to be snared within the renal pelvicaliceal system, the simple or modified snare technique was used for snaring of distal dj stent tip within the urinary bladder.Overall, 97.0% of the dj stents were removed using the simple or modified snare technique.Antegrade dj stent removal was performed in the urinary bladder in 4 patients (ie, 3 simple and 1 modified snare technique).In these patients, distal dj stent tip was able to be snared within the urinary bladder, using an antegradely inserted snare.There was no major complication during or after dj stent removal.Minor complications were observed in 25 dj stent removal procedures (12.4%).Complications included hematoma, pelvis injury, ureter injury, hematoma and pelvis injury, and ureteroileal fistula.All of the complications resolved spontaneously during the follow-up period and without further management.There was no significant difference in the complications risk between the simple (6.9%) and modified (8.5%) snare techniques.

• Brand Name: GOOSENECK SNARE
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; IE ; 091708734
• MDR Report Key: 10128800
• MDR Text Key: 200995506
• Report Number: 2183870-2020-00167
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K970668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/28/2020
• Initial Date FDA Received: 06/08/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR