MAUDE Adverse Event Report: COOK IRELAND LTD RESONANCE STENT SET; FAD STENT, URETERAL

Catalog Number RMS-060020-R

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problems Surgical procedure, repeated (2042); Surgical procedure, delayed (2565)

Event Date 10/28/2014

Event Type  Injury  

Event Description

The urologist tried to remove the resonance stent after the one year indwell time with a standard graspers during a cystoscopy.He cause the stent directly behind the orifice and pulled it out slowly.This action was difficult because there was opposition.Under x-ray you could see that the upper pigtail had not straightened out and was in the distal part of ureter as a closed pigtail.Additionally the stent was bent and later snapped off through the efforts to pull it out.Approx 1cm part of the inner safety wire of the resonance stent was outside of the stent and was visible in the bladder.The urologist made a urs with a very small rigid ureteroscope from olympus to find out the reason for the pigtail not straightening.The urologist placed an additional plastic stent close to the resonance stent and pushed back the lower pigtail into the bladder.The doctor has planned an additional procedure to remove the stent; a percutaneous nephrostomy and full narcosis to remove the stent antegradely.Currently no adverse effects to the patient are reported as a result of this occurrence.

Manufacturer Narrative

The urologist tried to remove the resonance stent with a standard graspers during a cystoscopy.He caught the stent directly behind the orifice and pulled out slowly.This action was difficult because there was opposition.Under x-ray you could see that the upper pigtail had not straightened out and was in the distal part of ureter as a closed pigtail.Additionally the stent was bent and later snapped off through the efforts to pull it out.Approx 1cm part of the inner safety wire of the resonance stent was outside of the stent and was visible in the bladder.The urologist made a urs with a very small rigid ureteroscope from olympus to find out the reason for the pigtail not straightening.The urologist placed an additional plastic stent close to the resonance stent and pushed back the lower pigtail into the bladder.The doctor plans a percutaneous nephrostomy and full narcosis to try to pull out the resonance stent antegrade at a later date.The cook sales rep clarified that the pigtail not straightening on removal did not cause any difficulty.The main issues were the upper pigtail was wedged, the lower pigtail had buckled and the inner safety wire had broken and was in the bladder.The device involved in this complaint has not been returned for evaluation; therefore, a document based investigation was carried out.The resonance stent remains in the patient and has been scheduled to be removed at a later date.The customer complaint was confirmed based on the customer testimony and photographs/images provided.A review of the manufacturing records for (b)(4) revealed no discrepancies that could have contributed to this complaint.Resonance stent devices are used for temporary stenting of the ureter in adult patients with extrinsic ureteral obstruction.These devices are intended for one-time use.As per instructions for use, ifu0020-14 removal or replacement of a resonance stent is standard procedure.A warning in the instructions for use, ifu0020-14, advises the following: "patients should be checked at regular intervals utilizing techniques such as abdominal x-ray (kub film).Use of this device should be based upon consideration of risk-benefit factors as they apply to your patient.Informed consent should be obtained to maximize patient compliance with f/u procedures".A final warning indicates that: "individual variations of interaction between stents and the urinary system are unpredictable".As per the instructions for use, ifu0020-14 step 7 instructs the user of the following: "the stent may be removed using conventional cystoscopic techniques utilizing forceps or graspers.Note: do not force components during removal or replacement.Carefully remove the components if any resistance is encountered".Prior to distribution, all resonance stent devices are subjected to visual inspections to ensure device integrity.These inspections are outlined in internal procedures in place at cirl.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: RESONANCE STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: sinead quaid, senior specialist ; 61334440
• MDR Report Key: 4287691
• MDR Text Key: 5190745
• Report Number: 3001845648-2014-00259
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K063742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/28/2014

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 Expiration Date: 10/03/2016
• Device Catalogue Number: RMS-060020-R
• Device Lot Number: C932192
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/28/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/29/2014
• Initial Date FDA Received: 11/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2013
• 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