MAUDE Adverse Event Report: COOK IRELAND LTD RESONANCE URETERAL STENT METALLIC STENT AND POSITIONER; FAD STENT, URETERAL

Catalog Number UNKNOWN

Device Problems Break (1069); Unraveled Material (1664); Use of Device Problem (1670)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

As reported to customer relations: "patient had stent placed at another facility (unknown facility), this was a scheduled stent removal.When they went to retrieve it, they said that the inner wire of the stent snapped during attempted retrieval, at which point the stent started to unravel.Unknown grasper was being used to extract.Customer was able to extract stent by pulling the wire, nothing had detached." fda mdr reporting required: event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent fracture/breakage/uncoiling' and 'difficult removal of stent'.No adverse effects to the patient have been reported as occurring.

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

As reported to customer relations: "patient had stent placed at another facility (unknown facility), this was a scheduled stent removal.When they went to retrieve it, they said that the inner wire of the stent snapped during attempted retrieval, at which point the stent started to unravel.Unknown grasper was being used to extract.Customer was able to extract stent by pulling the wire, nothing had detached." fda mdr reporting required: event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent fracture/breakage/uncoiling' and 'difficult removal of stent'.No adverse effects to the patient have been reported as occurring.

Event Description

As reported to customer relations: "patient had stent placed at another facility (unknown facility), this was a scheduled stent removal.When they went to retrieve it, they said that the inner wire of the stent snapped during attempted retrieval, at which point the stent started to unravel.Unknown grasper was being used to extract.Customer was able to extract stent by pulling the wire, nothing had detached." fda mdr reporting required: event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent fracture/breakage/uncoiling' and 'difficult removal of stent'.No adverse effects to the patient have been reported as occurring.

Manufacturer Narrative

Device evaluation 2 x rms-060024-r devices of unknown lot number involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.The images submitted with complaint confirmed the failure.Both stents were observed to be unraveled, with evidence of encrustation on the body of the stents and on the pigtails.The inner wire of the stent was broken.Document review prior to distribution rms-060024-r devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl a review of the manufacturing records for rms-060024-r of lot unknown could not be completed.It should be noted that the instructions for use (ifu0020-16) states the following: ¿warnings ¿these stents are not intended as permanent indwelling devices.¿the stent must not remain indwelling more than twelve (12) months.If the patient¿s status permits, the stent may be replaced with a new stent.¿ patients should be checked at regular interval utilizing techniques such as abdominal x-ray (kub film).Patient using calcium supplements must be more closely monitored for possible stent encrustation.The stent must be removed if encrustation hampers drainage¿ it may be noted that according to the instructions for use, ifu0020-16, the user is instructed that ¿the stent may be removed using conventional cystoscopic techniques utilizing forceps or grasper.Note: do not force components during removal or replacement.Carefully remove the components if any resistance is encountered.¿ there is evidence to suggest that the customer did not follow the instructions for use (ifu0020-16).Root cause review a definitive root cause could not be determined from the available information.A possible root cause could be attributed to the user leaving the stents in place for longer than the recommended indwell time and/or difficult patient anatomy.From the information provided it is known that the stent was left indwelling for 16 months.The ifu instructs that the stent should not remain in place for more than 12 months.The physician acknowledged the indwell period of the device is not to exceed the maximum 12 months indwell period.The physician who removed the stent did not perform regular monitor of the patient during the indwell period of the stent and it is unknown if this was performed elsewhere.This was a scheduled stent removal.When they went to retrieve it, they said that the inner wire of the stent snapped during attempted retrieval, at which point the stent started to unravel.An unknown grasper was used to extract the stent.The customer was able to extract stents by pulling the wire, nothing had detached within the patient.The physician who removed the stent did not perform regular monitoring of the patient during the indwell period of the stent and it is unknown if this was performed elsewhere.As the removed stents exhibited encrustation, it is likely the stents became imbedded in tissue growth over time and this may have impeded removal of the stents.The excessive force that was applied to remove the stents would have contributed to the stretching and unravelling of the stents.Summary complaint is confirmed as the failure was verified in the images.However, as the indwell period was exceeded, it is viewed as a user error.According to the initial reporter, the patient did not require any additional procedures or suffer any adverse effects as a result of this procedure.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

As reported to customer relations: "patient had stent placed at another facility (unknown facility), this was a scheduled stent removal.When they went to retrieve it, they said that the inner wire of the stent snapped during attempted retrieval, at which point the stent started to unravel.Unknown grasper was being used to extract.Customer was able to extract stent by pulling the wire, nothing had detached." fda mdr reporting required: event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent fracture/breakage/uncoiling' and 'difficult removal of stent'.No adverse effects to the patient have been reported as occurring.

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

• Brand Name: RESONANCE URETERAL STENT METALLIC STENT AND POSITIONER
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8944499
• MDR Text Key: 189900393
• Report Number: 3001845648-2019-00444
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• PMA/PMN Number: K063742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/01/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/01/2019
• Initial Date FDA Received: 08/29/2019
• Supplement Dates Manufacturer Received: 08/01/2019; 08/01/2019; 08/01/2019
• Supplement Dates FDA Received: 09/26/2019; 10/24/2019; 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1