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

Catalog Number RMS-060026-R

Device Problem No Flow (2991)

Patient Problem Urinary Retention (2119)

Event Date 07/21/2015

Event Type  Injury  

Manufacturer Narrative

Incident meets reporting criteria of an fda mdr report as the removal of the resonance stent is viewed as surgical intervention to prevent a serious injury.No device malfunction has been reported, the device not draining is interpreted as a performance related issue.Incident meets reporting criteria of an fda mdr report as the removal of the resonance stent is viewed as surgical intervention to prevent a serious injury.No device malfunction has been reported, the device not draining is interpreted as a performance related issue.

Event Description

Early (b)(6): urinary output stopped suddenly; therefore polyurethane stent was placed in the urinary duct.After placement, the patient was doing well.(b)(6) 2015: the physician replaced with resonance stent with consideration for prognosis.Rms-060026-r was placed for left urinary duct.Drainage of urine was confirmed.Foley catheter was placed in the urinary bladder.(b)(6) 2015: after removed foley catheter, urine was not draining.(b)(6) 2015: foley catheter was placed again, however, creatinine level was over 3.0.(b)(6) 2015: percutaneous nephrostomy was performed and urine was drained from the nephrostomy catheter temporally.Since renal function was improved, the physician cramped the nephrostomy catheter and waiting to observe urine output from the resonance.(b)(6) 2015: uo was 200cc.(b)(6) 2015: no uo.(b)(6) 2015: resonance was removed and dilatation of the nephrostomy.The physician was expected to see the urinary drainage from the resonance; however he could not see the good result after 2 weeks.Therefore, percutaneous nephrostomy was performed and drained from the nephrostomy catheter.He feels comfortable with nephrostomy catheter because urine drains surely.

Manufacturer Narrative

Incident meets reporting criteria of an fda mdr report as the removal of the resonance stent is viewed as surgical intervention to prevent a serious injury.No device malfunction has been reported, the device not draining is interpreted as a performance related issue.

Event Description

This follow up report is being submitted to include the device evaluation and investigation conclusions.(b)(6): urinary output stopped suddenly; therefore polyurethane stent was placed in the urinary duct.After placement, the patient was doing well.(b)(6) 2015: the physician replaced with resonance stent with consideration for prognosis.Rms-060026-r was placed for left urinary duct.Drainage of urine was confirmed.Foley catheter was placed in the urinary bladder.(b)(6) 2015: after removed foley catheter, urine was not draining.(b)(6) 2015: foley catheter was placed again, however, creatinine level was over 3.0.(b)(6) 2015: percutaneous nephrostomy was performed and urine was drained from the nephrostomy catheter temporally.Since renal function was improved, the physician cramped the nephrostomy catheter and waiting to observe urine output from the resonance.(b)(6) 2015: uo was 200cc.(b)(6) 2015: no uo.(b)(6) 2015: resonance was removed and dilatation of the nephrostomy.The physician was expected to see the urinary drainage from the resonance; however he could not see the good result after 2 weeks.Therefore, percutaneous nephrostomy was performed and drained from the nephrostomy catheter.He feels comfortable with nephrostomy catheter because urine drains surely.

Manufacturer Narrative

Incident meets reporting criteria of an fda mdr report as the removal of the resonance stent is viewed as surgical intervention to prevent a serious injury.No device malfunction has been reported, the device not draining is interpreted as a performance related issue.This complaint is related to 1 (b)(4) device of lot#c1073399.1 x resonance stent of unknown lot # was returned to cook (b)(4) for evaluation: on evaluation of the returned resonance device the stent was noted to be the correct shape.There were no signs of encrustation or blockages present within the coils on the stent when they were examined visually by the cirl senior manufacturing engineer.The wells of both ends of the stent were cut off.The safety wire was present and intact.A wire guide was passed through the stent and no resistance or blockages were met.A definitive cause for the customer¿s complaint of drainage difficulty was unable to be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy or progression of disease state, cook ireland could not reproduce the actual conditions of device usage.A possible cause of this complaint may be attributed to patient anatomy.The patient had pre existing medical conditions - uterine cervical cancer, complete obstruction of right urinary duct/obstruction of duodenum due to advanced uterine cervical cancer.The complaint was confirmed based on the customer testimony.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 removal or replacement of a resonance stent is standard procedure.Potential adverse events associated with indwelling ureteral stents include diminished urine drainage.A warning on the instructions for use 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 follow-up procedures¿.A final warning indicates that:¿individual variations of interaction between stents and the urinary system are unpredictable¿.Prior to distribution all resonance stent devices are subject to visual inspections to ensure device integrity.These inspections are outlined in internal procedures in place at cirl.A review of the manufacturing records for lot number c1073399 did not reveal any discrepancy related to the complaint issue.

Event Description

Early (b)(6): urinary output stopped suddenly; therefore polyurethane stent was placed in the urinary duct.After placement, the patient was doing well.On (b)(6) 2015: the physician replaced with resonance stent with consideration for prognosis.(b)(4) was placed for left urinary duct.Drainage of urine was confirmed.Foley catheter was placed in the urinary bladder.On (b)(6) 2015: after removed foley catheter, urine was not draining.On (b)(6) 2015: foley catheter was placed again, however, creatinine level was over 3.0.On (b)(6) 2015: percutaneous nephrostomy was performed and urine was drained from the nephrostomy catheter temporally.Since renal function was improved, the physician cramped the nephrostomy catheter and waiting to observe urine output from the resonance.On (b)(6) 2015: uo was 200cc.On (b)(6) 2015: no uo.On (b)(6) 2015: resonance was removed and dilatation of the nephrostomy.The physician was expected to see the urinary drainage from the resonance; however he could not see the good result after 2 weeks.Therefore, percutaneous nephrostomy was performed and drained from the nephrostomy catheter.He feels comfortable with nephrostomy catheter because urine drains surely.

• Brand Name: RESONANCE STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND; national technology park; castletroy limerick
• Manufacturer Contact: sinead quaid ; o'halloran road; national technology park; limerick ; EI ; 061334440
• MDR Report Key: 5009702
• MDR Text Key: 23216260
• Report Number: 3001845648-2015-00156
• 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
• Reporter Occupation: Physician
• Report Date: 09/08/2015

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: RMS-060026-R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/21/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2015
• 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