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

Model Number G34111

Device Problem Complete Blockage (1094)

Patient Problems Incontinence (1928); Inflammation (1932); Hematuria (2558)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported to customer relations: "stent placed in (b)(6) 2019 after 4 months ct performed and no hydronephrosis, so it looks as if the stent is draining.At 5 months patient became symptomatic and continues to be with "gross hematuria, urgency and urge incontinence." cystoscopy performed and distal portion of stent was encrusted and bladder is inflamed".Additional information provided by dm on 29apr2020: "can you indicate the date on which the customer discovered this issue? according to dr.(b)(6) the patient became symptomatic approximately one month ago." stent will be removed and replaced with a plastic stent on (b)(6).

Manufacturer Narrative

The device involved in the complaint was evaluated in laboratory on (b)(6) 2020.In summary the following results were observed in the lab evaluation.Encrustation was observed on one pigtail of the stent.Only the rms stent was returned for evaluation.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

As reported to customer relations: "stent placed in (b)(6) 2019 after 4 months ct performed and no hydronephrosis, so it looks as if the stent is draining.At 5 months patient became symptomatic and continues to be with "gross hematuria, urgency and urge incontinence." cystoscopy performed and distal portion of stent was encrusted and bladder is inflamed." additional information provided by dm on 29apr2020: "can you indicate the date on which the customer discovered this issue? according to dr.(b)(6) the patient became symptomatic approximately one month ago." stent will be removed and replaced with a plastic stent on (b)(6).

Event Description

As reported to customer relations: "stent placed in december 2019 after 4 months ct performed and no hydronephrosis, so it looks as if the stent is draining.At 5 months patient became symptomatic and continues to be with "gross hematuria, urgency and urge incontinence." cystoscopy performed and distal portion of stent was encrusted and bladder is inflamed" additional information provided by dm on 29apr2020: "can you indicate the date on which the customer discovered this issue? according to dr.Bascom the patient became symptomatic approximately one month ago." stent will be removed and replaced with a plastic stent on (b)(6).

Manufacturer Narrative

1 x rms-060026-r of lot number c1661454 was returned to cirl for a lab evaluation.It was returned used and not in its original packaging.Returned images also confirm evidence of encrustation.In summary the following results were observed in the lab evaluation.Encrustation was observed on one pigtail of the stent.Only the rms stent was returned for evaluation.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-060024-r of lot number c1661454 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 c1661454.The instructions for use, which accompanies this device warns of the following ¿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¿.It may be noted that according to the instructions for use, instructs the user in step 7: ¿the stent may be removed using conventional cystoscopic techniques utilizing forceps or grasper.Note: do not force components during removal or replacement.Carefully remove the components if any resistance is encountered.¿ a final warning in the instructions for use indicates that: ¿individual variations of interaction between stents and the urinary system are unpredictable¿ there is not sufficient evidence to suggest that the user did not follow the ifu.A definitive root cause could not be determined from the available information.A possible root cause could be attributed to patient condition related.The root cause of the calcification/encrustation may be the result of the patient's anatomical environment and pre-existing conditions.The patient is has extrinsic compression of ureter.The stent had evidence of encrustation present on one pigtail, this encrustation would have blocked the lumen of stent causing it to cease draining.The patient¿s existing condition of a constricted ureter due to malignancy, could have created an environment within the patient where encrustation could have developed on the stent 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.Complaint is confirmed based on the customers testimony as the clinical setting that could impact on the functionality of the device cannot be replicated in the laboratory.The stent was placed in december 2019 after 4 months ct performed and no hydronephrosis was present.At 5 months indwell period the patient became symptomatic and continues to be with "gross hematuria, urgency and urge incontinence." cystoscopy performed and distal portion of stent was encrusted and bladder is inflamed.The stent was removed on the 30th of april 2020.Patient's condition now is unknown complaints of this nature will continue to be monitored for 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: 10086200
• MDR Text Key: 191977461
• Report Number: 3001845648-2020-00311
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002341118
• UDI-Public: (01)10827002341118(17)221021(10)C1661454
• 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: 09/18/2020

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: 10/21/2022
• Device Model Number: G34111
• Device Catalogue Number: RMS-060026-R
• Device Lot Number: C1661454
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/08/2020
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/28/2020
• Initial Date FDA Received: 05/26/2020
• Supplement Dates Manufacturer Received: 04/28/2020; 04/28/2020
• Supplement Dates FDA Received: 07/08/2020; 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention