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

Model Number G34111

Device Problem Obstruction of Flow (2423)

Patient Problem Failure of Implant (1924)

Event Date 01/15/2019

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

Product stop working as designed."as per complaint form": after 3 weeks the rms doesn't work.Product stop working as designed.Fda mdr reporting required - reporting required based on the requirement for a surgical intervention as "the physician had to remove the stent and place another device to provide drainage for urine".Also reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent occlusion/encrustation and device not draining".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 mfr site 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: 3005580113.Device evaluation: 1 x rms-060026-rof lot # c1551584 was returned to cirl for a lab evaluation.It was returned used and not its¿ original packaging.Lab evaluation: the device involved in the complaint was evaluated in laboratory on 14th of february 2019.In summary the following results were observed in the lab evaluation.Residue was observed on the stent.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.Image review: n/a.Documents review: a review of the manufacturing records for rms-060026-r device of lot number c1551584 did not reveal any discrepancies that could have contributed to the issue.There was a non-conformance ( nc code pac-027) raised against this lot no.C15515842 but it was unrelated to this failure.There is no evidence to suggest that this issue affects the entire lot # c1551584; upon review of complaints this failure mode has not occurred previously with this lot # c1551584.Prior to distribution, all rms-060026-r 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 "complete a 100% visual inspection of the packaged unit while held at a comfortable arm¿s length from the unaided eye at normal lighting conditions." in the final quality control check, the manufacturing team member performs the following check as per step 4.2 ¿check for kinks or damage along stent length.¿ and also step 4.8.¿review the work order, to ensure 100% proof load test has been completed successfully¿.The instructions for use, ifu0020-15, which accompanies this device warns of the following ¿patients should be checked at regular intervals utilizing techniques such as abdominal x-ray.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, ifu0020-15, it warns the user: ¿if any resistance is encountered when removing the ureteral stent, determine the cause of the resistance by such as x-ray examination and perform appropriate treatment.Forceful removal may result in damage to the renal pelvis and the ureter.¿ a final warning indicates that: ¿individual variations of interaction between stents and the urinary system are unpredictable¿.There is no evidence to suggest the user did not follow the instructions for use.Root cause (possible): 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 could be attributed to the patient¿s anatomy or progression of disease state.The patient is condition is prostate cancer and he has a condition of hydronephrosis.As per the additional information received on 01st of april, ¿the hydronephrosis was caused by pressure from the cancer on ureter¿ and they also confirmed the rms stent was being been to extrinsic ureteral obstruction.As per additional information received, the patient was checked regularly, twice with ultrasound scanning.The stent was removed after 3 weeks, it was implanted on (b)(6) 2019 and removed on (b)(6) 2016 as it ceased working on (b)(6) 2019.The stent was removed with alligator forceps and extra force was required to remove the stent due the patient¿s condition of hydronephrosis.Based on the customer¿s testimony, our clinical reviewer, has stated the rms was designed especially to resist extrinsic compression and should not be compromised just within 3 weeks.If the feedback information from physician was accurate, then it was a stent failure.So based on the information received from the customer and our clinical reviewer¿s input, it is possible that the patient¿s condition progressed within that time frame and applied pressure on the stent and this may have caused the stent to be compressed and become blocked preventing it from draining as described within the complaint.Summary: complaint is confirmed as the failure was based on customer¿s testimony.The patient did not experience any adverse effects due to this occurrence.

Event Description

Product stop working as designed."as per complaint form": after 3 weeks the rms doesn't work.Product stop working as designed.Fda mdr reporting required - reporting required based on the requirement for a surgical intervention as "the physician had to remove the stent and place another device to provide drainage for urine".Also reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent occulsion/encrustation and device not draining".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)(6).Importer site establishment registration number: (b)(4).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Product stop working as designed."as per complaint form": after 3 weeks the rms doesn't work.Product stop working as designed.Fda mdr reporting required - reporting required based on the requirement for a surgical intervention as "the physician had to remove the stent and place another device to provide drainage for urine".Also reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent occulsion/encrustation and device not draining".No adverse effects to the patient have been reported as occurring.

• Brand Name: RESONANCE STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8389969
• MDR Text Key: 137806597
• Report Number: 3001845648-2019-00086
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002341118
• UDI-Public: (01)10827002341118(17)211022(10)C1551584
• 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: 04/02/2019

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: 10/22/2021
• Device Model Number: G34111
• Device Catalogue Number: RMS-060026-R
• Device Lot Number: C1551584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/05/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/05/2019
• Initial Date FDA Received: 03/05/2019
• Supplement Dates Manufacturer Received: 02/05/2019; 02/05/2019
• Supplement Dates FDA Received: 04/02/2019; 04/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention