MAUDE Adverse Event Report: COOK INC FILIFORM DOUBLE PIGTAIL URETERAL STENT SET; FAD STENT, URETERAL

Catalog Number UNKNOWN

Device Problem Migration (4003)

Patient Problems Internal Organ Perforation (1987); Infection, Pyrogenic (2246)

Event Type  Injury  

Manufacturer Narrative

(b)(6).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It is reported in the case report published in a 2014 issue of the central european journal of urology that a (b)(6) old female patient presented with repeated episodes of febrile urinary tract infections (uti) following the placement of a cook filiform double pigtail ureteral stent set.Details and sequence of events are as follows: relevant patient medical history: patient was treated approximately 11 years prior to these events for carcinoma of the cervix.Treatment included chemotherapy and radiation therapy.The patient achieved complete resolution of the primary disease.The patient presented with intermittent gross hematuria of three days duration "five months ago".At the time of this presentation, the patient was found to have radiation cystitis, and suspected stricture of the right ureter.A cook 6fr, 26cm filiform double pigtail ureteral stent was inserted (performed at another unspecified hospital).After three months the cook 6fr, 26cm filiform double pigtail ureteral stent was exchanged.Fluoroscopy was not used for the exchange procedure ( also performed at another unspecified hospital).Post-operatively, the patient developed three episodes of febrile uti, each lasting 5-7 days.Each episode was treated with unspecified parenteral antibiotics.The patient was transferred to the specialty hospital for evaluation of the cause of fevers.A computerized tomography (ct) was ordered, and this revealed an extrusion of the upper end of the cook 6fr, 26cm filiform double pigtail ureteral stent outside the renal parenchyma.A review of previous x-rays completed revealed the same findings, this finding was apparently missed earlier.The stent was removed cystoscopically.A retrograde pyelogram showed a normal ureter, so the stent was not replaced.The patient was started on a 14 day course of an unspecified broad spectrum antibiotic.The patient's symptoms were relieved, with no further episode of uti in the three month follow-up period.A dtpa renal scan showed normal function and drainage of both kidneys.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Event description: it is reported in the case report published in a 2014 issue of the central european journal of urology that a 62-year-old female patient presented with repeated episodes of febrile urinary tract infections (uti) following the placement of a cook filiform double pigtail ureteral stent set.After three months the cook 6fr, 26cm filiform double pigtail ureteral stent was exchanged.Fluoroscopy was not used for the exchange procedure.Post-operatively, the patient developed three episodes of febrile uti, each lasting 5-7 days.Each episode was treated with unspecified parenteral antibiotics.The patient was transferred to the specialty hospital for evaluation of the cause of fevers.A computerized tomography (ct) was ordered, and this revealed an extrusion of the upper end of the cook 6fr, 26cm filiform double pigtail ureteral stent outside the renal parenchyma.A review of previous x-rays completed revealed the same findings, this finding was apparently missed earlier.The stent was removed cystoscopically.A retrograde pyelogram showed a normal ureter, so the stent was not replaced.The patient was started on a 14-day course of an unspecified broad-spectrum antibiotic.The patient's symptoms were relieved, with no further episode of uti in the three-month follow-up period.A dtpa renal scan showed normal function and drainage of both kidneys.Investigation ¿ evaluation.A document-based investigation was performed including a review of instructions for use (ifu), and quality control data.The complaint device was not returned; therefore, no physical examinations could be performed.A review of the device history record could not be completed due to lack of lot information from the user facility.A review of the complaint history could not be completed due to lack of information from the user facility.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: "1.Advance the flexible end of the stent assembly, under cystoscopic vision, into the ureteral orifice.Advancement of the stent up the ureter is accomplished under fluoroscopic control.5.Fluoroscopically confirm the position of the stent coils in the bladder and renal pelvis." a clinical assessment was conducted and concluded that based on the available information, the likely causes for this event include patient condition and failure to follow the instructions for placing the stent.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No new patient or event information since the last report was submitted.

• Brand Name: FILIFORM DOUBLE PIGTAIL URETERAL STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10188781
• MDR Text Key: 199725250
• Report Number: 1820334-2020-01176
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• PMA/PMN Number: K172017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 09/01/2020

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/17/2020
• Initial Date FDA Received: 06/24/2020
• Supplement Dates Manufacturer Received: 08/28/2020
• Supplement Dates FDA Received: 09/01/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR