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

Model Number G34111

Device Problem Obstruction of Flow (2423)

Patient Problems Fever (1858); Swelling (2091)

Event Date 07/22/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The 2 complaint rms-060026-r (c1532332x2) were used for transurethral ureteral stenting, and placed on (b)(6) 2019.However, the 2 complaint device were exchanged with another resonance stent on july 22th, 2019 because it was observed that the patient had hydronephrosis and fever.After the removal of the complaint device.It was confirmed that there was a little stain on the surface of the device.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 as the patient experienced hydronephrosis and intervention was required to exchange the stents, also reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent does not drain'.

Event Description

The 2 complaint rms-060026-r (c1532332x2) were used for transurethral ureteral stenting, and placed on march 1st, 2019.However, the 2 complaint device were exchanged with another resonance stent on (b)(6)2019 because it was observed that the patient had hydronephrosis and fever.After the removal of the complaint device.It was confirmed that there was a little stain on the surface of the device.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 as the patient experienced hydronephrosis and intervention was required to exchange the stents, also reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent does not drain.'.

Manufacturer Narrative

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

Manufacturer Narrative

Device evaluation: 2 x rms-060026-r devices of lot number c1532332 involved in this complaint was returned for evaluation, without the original packaging.With the information provided, a physical examination and document based investigation was conducted.Lab evaluation: the devices related to this occurrence underwent a laboratory evaluation on the 16th august 2019.On evaluation of the both stents had evidence of encrustation on the body of the stents.Document review: prior to distribution rms-060026-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 for rms-060026-r of lot number c1532332 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records, confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1532332.The instructions for use, ifu which accompanies this device instructs the end user to ¿ patients should be checked at regular intervals utilizing techniques such as abdominal x-ray(kub film).Patient using calcium supplements must be more closely monitored for possible stent encrustation.The stent must be removed if encrustation hampers drainage.¿ it should also be noted that the ifu lists diminished urine drainage / stent occlusion/ stent encrustation as a known potential adverse event.There is no evidence to suggest that the customer did not follow the instructions for use.Image review ¿ n/a.Root cause review: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to patient condition related.Both stents had evidence of encrustation present, this encrustation would have blocked the lumen of stents causing them to cease draining.The patient¿s existing condition of a constricted ureter due to malignancy, and hydronephrosis could have created an environment within the patient where encrustation could have developed on the stents due to interactions with the patient¿s anatomy.As per instructions for use, diminished urine drainage/ stent occlusion/ stent encrustation are listed as a complication following the placement of the device.Summary: complaint is confirmed as the failure was verified in the laboratory.According to the initial reporter, the patient had hydronephrosis and fever.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

The 2 complaint rms-060026-rs (c1532332x2) were used for transurethral ureteral stenting, and placed on (b)(6) 2019.However, the 2 complaint devices were exchanged with another resonance stent on (b)(6) 2019 because it was observed that the patient had hydronephrosis and fever.After the removal of the complaint device.It was confirmed that there was a little stain on the surface of the device.

• Brand Name: RESONANCE STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; national technology park; limerick
• MDR Report Key: 8906915
• MDR Text Key: 156334162
• Report Number: 3001845648-2019-00419
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002341118
• UDI-Public: (01)10827002341118(17)210828(10)C1532332
• 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: 09/16/2019

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 Expiration Date: 08/28/2021
• Device Model Number: G34111
• Device Catalogue Number: RMS-060026-R
• Device Lot Number: C1532332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/22/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/25/2019
• Initial Date FDA Received: 08/19/2019
• Supplement Dates Manufacturer Received: 07/25/2019; 07/25/2019
• Supplement Dates FDA Received: 09/16/2019; 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention