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

Catalog Number RMS-060022-R

Device Problem Obstruction of Flow (2423)

Patient Problem Inflammation (1932)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Document review including ifu review: prior to distribution rms-060022-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 could not be complete as the lot number is unknown.As per instructions for use, ifu0020-16, ¿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 intervals utilizing techniques such as abdominal x-ray (kub film).Patients using calcium supplements must be more closely monitored for possible stent encrustation.The stent must be removed if encrustation hampers drainage.¿ ¿potential adverse events associated with indwelling ureteral stents include: diminished urine drainage/stent occlusion, fistula formation including arterioureteral fistula, hemorrhage, hydronephrosis, infection, loss of renal function, pain/discomfort, perforation of kidney, renal pelvis, ureter and/or bladder, peritonitis, pyuria, stent degradation/fracture, stent dislodgement/migration, stent encrustation, tissue ingrowth, ureteral reflux, urinary symptoms (frequency, urgency, incontinence, dysuria, hematuria), urinary tract tissue erosion.¿ root cause review: information provided: ¿2.3.3 how long was the stent in-dwelling? 12+ months 2.3.5 how often was the stent checked during the in-dwelling time? physician did not provide information¿ a definitive root cause could not be determined from the available information.A possible root cause may be attributed to the indwell time of the stent being exceeded.It is also not stated if the patient had routine check-ups which is also stated to be carried out in the ifu.Summary: complaint is confirmed based on customer testimony.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence but required an additional procedure to place an alternative stent.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

As initially reported to customer relations: a female patient of unknown age had a resonance stent, g34109, placed approximately 12 months prior to this event.With the indwell time the physician had planned to do a normal stent exchange.The stent was removed using graspers.The physician was going to place another of the same stent however the wire was unable to go back up due to inflammation in the ureter, therefore a regular stent, bard inlay stent, was placed instead.Fda mdr reporting required: this event meets the criteria of an fda ¿serious injury¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿ section 2.13 and 2.15 based on the requirement for surgical intervention as another device was placed, also based on the device malfunction reporting precedence for this device family for the issue of "stent does not drain".

• Brand Name: RESONANCE STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: heather ryan ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 8691687
• MDR Text Key: 147743217
• Report Number: 3001845648-2019-00258
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Type of Report: Initial
• Report Date: 05/15/2019

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: RMS-060022-R
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/16/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/16/2019
• Initial Date FDA Received: 06/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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