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

Catalog Number RMS-060024-R

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Urinary Retention (2119); Surgical procedure, additional (2564)

Event Date 01/05/2015

Event Type  Injury  

Event Description

A pt with ureterostenosis due to rectal cancer had another manufacturer's stent (brad's inlay stent, 6fr/26cm) in each urinary duct.The pt had been bedridden, had cloudiness of urine and an ileovesical fistula had been confirmed.On (b)(6) 2014, the inlay stent in the left side was removed and the resonance stent was placed.The inlay stent in the right side was also removed, but a new stent could not be inserted because the stenosed site closed, so it was left without a stent.On (b)(6) 2015: drainage was no problem with 2400 ml of urine output.On (b)(6) 2015: uo decreased to 150 ml.Creatinine level was 2.4.By (b)(6) 2015, the pt's creatinine level increased to 8.18.The physician diagnosed this as hydronephrosis.The doctor replaced the resonance stent with a polymer stent (boston scientific's polaris stent).The pt's uo and creatinine level improved.

Manufacturer Narrative

Additional info received relating to the removal of the rms device was received as follows: the inside of the pt's bladder was in a bad condition so the doctor and the sales rep determined it would be difficult to locate the ureteral orifice after removing the resonance stent.So the stent was pulled out to the point where the doctor can see with the naked eye, and then he stitched it to a introducer from another resonance stent set.The coiling of the stent was stretched by a forceps to make the 3.0 nylon thread into the coiling at this point.Then a sheath from another resonance set was advanced over them, and the introducer and the stent was removed.He used the remained sheath to cannulate with a guide wire and the polymer stent was placed.The pt's pre-existing conditions were confirmed as follows: "rectal cancer, contracted bladder due to radiation therapy in the past, cancer invation in bladder, ileovesical fistula, cloudiness of urine." the (b)(4) device involved in this complaint has not been returned for evaluation.The complaint was confirmed based on the customer testimony.The root cause of this complaint cannot be conclusively determined, as the device has not been returned for evaluation.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 ifu0020-14, instructions for use, potential adverse events associated with indwelling ureteral stents include diminished urine drainage and hydronephrosis.A warning on 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." 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 inspection to ensure device integrity.A review of the manufacturing records for lot number c1004293 did not reveal any discrepancy related to the complaint issue.The doctor replaced the resonance stent with a polymer stent (boston scientific's polaris stent).The patient's uo and creatinine level improved.No further adverse effects to the pt have been reported as occurring.No complaints of this nature will be 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, sr. specialist ; EI ; 61334440
• MDR Report Key: 4501542
• MDR Text Key: 19797816
• Report Number: 3001845648-2015-00019
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 01/10/2015

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 Expiration Date: 05/28/2017
• Device Catalogue Number: RMS-060024-R
• Device Lot Number: C1004293
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/05/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/21/2015
• Initial Date FDA Received: 02/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2014
• 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
• Patient Age: 59 YR