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

Catalog Number 039500-8-20

Device Problem Knotted (1340)

Patient Problems Abdominal Pain (1685); Vomiting (2144)

Event Type  Injury  

Manufacturer Narrative

Pt identifier) unknown as not provided.Sex) unknown as not provided.Weight) unknown as not provided.Date of event) unknown as not provided.Lot # unknown as not provided.Expiration date unknown as lot is unknown.Udi #: unknown as lot is unknown.Is this is a single use device that was reprocessed and reused on a pt?) unknown as not provided.Initial reporter) unknown as not provided.Health professional?) unknown as not provided.User facility or importer nae/address) unknown as not provided.Contact person) unknown as not provided.Phone number) unknown as not provided.Date user facility or importer became aware of event) unknown as not provided.Approximate age of device) unknown as not provided.(b)(4).Device manufacture date) unknown as no lot # was provided.The event is currently under investigation.

Event Description

As published in the 2005 article "knotting of a ureteric stent in a child": re-implementation of an obstructed mega-ureter was performed over a 4.7 fr multi-length ureteric stent in a (b)(6) child.The child returned for stent removal eight weeks later.Resistance was encountered during stent withdrawal and a knot was apparent in the proximal loop of the stent after its removal.Twenty four hours later the child complained of abdominal pain and began vomiting.Ultrasound scan showed gross left hydronephroureter.The child was admitted to hospital for observation.The symptoms settled over the following 48 hours without the need for intervention.Urea, electrolytes, creatinine and blood pressure remained normal.Serial ultrasound scans showed a return to preoperative dimensions over the next 14 days.The child made a full recovery.

Manufacturer Narrative

Investigation - evaluation: a review of the complaint history, instruction for use (ifu), specifications and trends was conducted during the investigation.The device is shipped with an instruction for use (ifu) that cautions: "complications of ureteral stent placement are documented in literature.Use of this device should be based upon consideration of risk benefit factors as they apply to your patient.Individual variations of interaction between stents and urinary tract systems are unpredictable".The ifu also states that "improper handling can seriously weaken the stent".The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history and non-conformances was not possible as the lot number was not available.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.The appropriate internal personnel have been notified.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: SOF-FLEX MULTI-LENGTH URETERAL STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK UROLOGICAL INC; 1100 west morgan st; spencer IN 47460
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 5672968
• MDR Text Key: 45696939
• Report Number: 1820334-2016-00336
• Device Sequence Number: 1
• Product Code: FAD
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/28/2016

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
• Device Catalogue Number: 039500-8-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/02/2016
• Initial Date FDA Received: 05/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/18/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 4 YR