MAUDE Adverse Event Report: COOK INC SOF-FLEX PEDIATRIC MULTI-LENGTH URETERAL STENT SET; FAD STENT, URETERAL

Catalog Number UNKNOWN

Device Problem Material Deformation (2976)

Patient Problems Abdominal Pain (1685); Vomiting (2144); Swelling/ Edema (4577)

Event Date 09/30/2022

Event Type  Injury  

Manufacturer Narrative

Initial reporter postal code: (b)(6).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.

Event Description

As reported in the literature by corbett & dickson (2005), an unspecified cook 4.7 french soft-flex multi-length stent knotted within a pediatric patient.The stent was originally placed for an obstructed mega-ureter after pyeloplasty, to protect an anastomosis and ensure post-operative kidney drainage.The stent was removed eight weeks later.Resistance was encountered during withdrawal of the stent and a knot was found in the proximal loop after removal.The authors state that the stent was not difficult to remove but some trauma did occur, which put the kidney at risk.Twenty-four hours later, the patient developed abdominal pain and vomiting.Ultrasound noted gross left hydronephroureter, and the patient was admitted to the hospital for observation.The symptoms subsided over the following 48 hours without any intervention.Lab values and blood pressure remained normal.Serial ultrasounds showed a return to pre-operative dimensions over the following 14 days.The authors conclude that multi-length stents should probably be avoided in children and that users should be aware of the possibility of knotting, especially if resistance is encountered upon stent withdrawal.Reference for article: corbett, h.J.& dickson, a.P.(2005).Knotting of a ureteric stent in a child.International urology and nephrology (37), p.493-494.Doi: 10.1007/s11255-005-2084-1.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Correction: this pr was determined to be a duplicate of (b)(4) (mdr #: 1820334-2016-00336) and has already been reported.There is no new information to report.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.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: SOF-FLEX PEDIATRIC MULTI-LENGTH URETERAL STENT SET
• Type of Device: FAD STENT, URETERAL
• 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: 15724892
• MDR Text Key: 303047580
• Report Number: 1820334-2022-01682
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 01/31/2023
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 4 YR