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

Catalog Number RMS-060024-R

Device Problems Partial Blockage (1065); Obstruction of Flow (2423)

Patient Problems Occlusion (1984); Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The stent was not allowing the patient to drain.The physician had to remove the stent and place a nephrostomy tube to provide drainage for urine.Reporting required based on the requirement for a surgical intervention.

Manufacturer Narrative

Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Importer site contact and address: (b)(6).Cook medical incorporated (cmi) (b)(4).Importer site establishment registration number: (b)(4).Lab evaluation: 1 x rms-060024-r of an unknown lot number was the subject of this complaint.1 x rms-060024-r device (used ) of an unknown lot number was returned to cirl on 31 jul 2018.A lab evaluation was held on 02 aug 2018.Encrustation was observed on the middle of stent and indicates compressing tight stricture.Visible encrustation may cause drainage issues.Nephrostomy indicates a very torturous stricture.The location of the encrustation indicates a very tight stricture which potentially prevented drainage.Very tight stricture around the center of the stent may have caused poor drainage and encrustation which then exacerbated the drainage difficulties.Root cause: a definitive root cause for the customer complaint could not be determined as the exact operational conditions of use could not be replicated in the laboratory setting.A possible root cause may be attributed to extrinsic compression.The tensile strength may not be high enough to resist the compression.The very tight stricture around center of stent may have caused poor drainage and encrustation which then exacerbated the drainage difficulties.The complaint is confirmed as the failure was verified in the laboratory and the stent was found to have a very tight stricture around the center which may have caused poor drainage and encrustation which then exacerbated the drainage difficulty.Summary: the complaint is confirmed based on the customer¿s testimony.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Reporting required based on the requirement for a surgical intervention."the stent was not allowing the patient to drain.The physician had to remove the stent and place a nephrostomy tube to provide drainage for urine.".

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)(6).Cook medical incorporated (cmi) (b)(4).Importer site establishment registration number: (b)(4).Problem statement: "the stent was not allowing the patient to drain.The physician had to remove the stent and place a nephrostomy tube to provide drainage for urine." additional information 29th may 2018: what alerted the drs to the fact that the stent was not draining? the patient was having flank pain that is what alerted him to it not draining did the patient suffer any adverse effects as a result of the issue? no adverse effects on the patient was the reason for the issue identified, i.E.Was the stent damaged/occluded/encrusted? stent wasn¿t damaged or encrusted and wasn¿t really certain if the stent failed, he felt it was the patients disease, i.E.To strong of extrinsic compression that didn¿t allow to drain.Additional information 7th june 2018: failed stent had to be removed, nothing was left in the patient from this original stent.I believe the date of implant was (b)(6) 2017.The stent was removed from the ureter, the stent was removed because the patient still wasn¿t draining urine i.E.The stent was failing.The patient¿s anatomy had extrinsic compression and i believe had a runny substance that always coated stents if i recall correctly in his terms, i don¿t have any videos or images.I don¿t have a lot number or anything of that sort and i don¿t have the stent to be returned.The outcome was that the surgeon had a nephostomy tube in as well and once he removed the metallic stent, there was drainage from the neph tube.Additional information 27th june 2018: feedback from the rep indicated the following: ¿to my knowledge the surgeon did not say anything to me about stent compression or deformity".Lab evaluation: 1 x rms-060024-r of an unknown lot number was the subject of this complaint.The device was not returned for evaluation.Therefore, a document based investigation was completed.Clinical review: the medical advisor at cook ireland reviewed the complaint.The feedback is as follows: the possible failure mode would be stent occlusion; urine cannot pass through and nephrostomy is required.The root cause would be extrinsic compression; the tensile strength might not be high enough to resist the compression.Root cause: a definitive root cause for the customer complaint could not be determined as the exact operational conditions of use could not be replicated in the laboratory setting.A possible root cause may be attributed to extrinsic compression.The tensile strength may not be high enough to resist the compression.The complaint is confirmed based on the customer¿s testimony.Fqc/pkg review: prior to distribution, all rms devices are subjected to 100% inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.There is also a visual inspection of the product and packaging at packaging, packaging qc, and post sterile qc.Ifu review: it may be noted that the instructions for use, list "diminished urine drainage/stent occlusion" as a potential adverse event associated with indwelling ureteral stents.The ifu also warns that: "individual variations of interaction between stents and the urinary system are unpredictable.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.¿ summary: the complaint is confirmed based on the customer¿s testimony.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Reporting required based on the requirement for a surgical intervention."the stent was not allowing the patient to drain.The physician had to remove the stent and place a nephrostomy tube to provide drainage for urine.".

• Brand Name: RESONANCE STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7591584
• MDR Text Key: 110752650
• Report Number: 3001845648-2018-00268
• 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
• Report Date: 08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RMS-060024-R
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/12/2018
• Event Location: Hospital
• Date Manufacturer Received: 05/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention