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

Catalog Number RMS-060022-R

Device Problem Material Erosion (1214)

Patient Problem Discomfort (2330)

Event Date 05/13/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Potential traumatic hypospadias of the left trigon due to erosion from the stent.Update 16may2019: in an email from the area representative received 16may2019 by reg reporting ((b)(6)) the following information has been made available: the patient was confirmed to be a female, thus could not have hypospadias, however was stated to have an issue with the vesical trigone.She experienced an increased extrinsic compression on the ureter.Malignancy cannot be confirmed.The physician does not think that the prolonged indwell time caused or contributed to the issue with the device.The patient did not come in for routine check-ups during the time the stent was indwelt.The stent was originally placed due to the increased extrinsic compression on the ureters, thus causing hydronephrosis.(b)(6) 16may2019.Fda mdr reporting required: this event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent erosion'.No adverse effects to the patient have been reported as occurring.

Event Description

Potential traumatic hypospadias of the left trigon due to erosion from the stent.Update 16may2019: in an email from the area representative received 16may2019 by reg reporting (mprice) the following information has been made available: the patient was confirmed to be a female, thus could not have hypospadias, however was stated to have an issue with the vescial trigone.She experienced an increased extrinsic compression on the ureter.Malignancy cannot be confirmed.The physician does not think that the prolonged indwell time caused or contributed to the issue with the device.The patient did not come in for routine check-ups during the time the stent was indwelt.The stent was originally placed due to the increased extrinsic compression on the ureters, thus causing hydronephrosis.Mnp 16may2019 fda mdr reporting required: this event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent erosion'.No adverse effects to the patient have been reported as occurring.

Manufacturer Narrative

Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4).Cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington, indiana, 47402-4195.Importer site establishment registration number: (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: ¿what was the length of the indwell time? 1 year and 3 months¿ how often was the stent checked during the in-dwelling time? 1 to 2 times.Patient did not come in for routine checkups.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 was commented by the physician that he/she ¿does not think that the prolonged indwell time caused or contributed to the issue¿, however, it is not possible to determine if this is the case or not, as the indwell time was exceeded, it is possible that the issues encountered could have been a result of the stent being left in longer that stated in the ifu.It is also stated that the patient did not come in for 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 has experienced potential traumatic hypospadias of the left trigon due to erosion from the stent.This was clarified not to be the case as the patient is female and it was then stated that the patient had ¿an issue with the vescial trigone¿.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; o halloran road; limerick
• MDR Report Key: 8682688
• MDR Text Key: 150145045
• Report Number: 3001845648-2019-00251
• 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
• Report Date: 06/10/2019

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: RMS-060022-R
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/10/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/16/2019
• Initial Date FDA Received: 06/10/2019
• Supplement Dates Manufacturer Received: 05/16/2019
• Supplement Dates FDA Received: 07/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1