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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD RESONANCE STENT SET; FAD STENT, URETERAL
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COOK IRELAND LTD RESONANCE STENT SET; FAD STENT, URETERAL Back to Search Results
Model Number G34111
Device Problems Break (1069); Stretched (1601)
Patient Problems Failure of Implant (1924); Occlusion (1984); No Known Impact Or Consequence To Patient (2692)
Event Date 12/21/2018
Event Type  Injury  
Manufacturer Narrative
510 (k) number: k063742.(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
When the physician attempted to remove the stent, he felt it was caught at the upper part of the renal pelvis.After all, he could remove the stent by drawing it.However, he found the outer coil of the stent got untied/unraveled and stretched.A section of the device did not remain inside the patient.Updates on dec 28th by (b)(4): "when the physician attempted to remove the stent for placing a new stent, he felt it was caught at the upper part of the renal pelvis.After all, he could remove the stent by drawing it.However, he found the wire guide in the coil broke and the outer coil of the stent got untied/unraveled and stretched.A section of the device did not remain inside the patient.".
 
Event Description
When the physician attempted to remove the stent, he felt it was caught at the upper part of the renal pelvis.After all, he could remove the stent by drawing it.However, he found the outer coil of the stent got untied/unraveled and stretched.A section of the device did not remain inside the patient.Updates on dec 28th by at (b)(6).When the physician attempted to remove the stent for placing a new stent, he felt it was caught at the upper part of the renal pelvis.After all, he could remove the stent by drawing it.However, he found the wire guide in the coil broke and the outer coil of the stent got untied/unraveled and stretched.A section of the device did not remain inside the patient.Updates2 on dec 28th by at (b)(6)." however, he found the wire guide in the coil broke " "however, he found the wire guide in the stent broke" when the physician attempted to remove the stent for placing a new stent, he felt it was caught at the upper part of the renal pelvis.After all, he could remove the stent by drawing it.However, he found the wire guide in the stent broke and the outer coil of the stent got untied/unraveled and stretched.A section of the device did not remain inside the patient.Fda mdr reporting required - event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent fracture/break/uncoiling.No adverse effects to the patient have been reported as occurring.
 
Manufacturer Narrative
510 (k) number; k063742 cook ireland ltd (manufacturer) is submitting this report on behalf of (b)(4) (importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4), 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
When the physician attempted to remove the stent, he felt it was caught at the upper part of the renal pelvis.After all, he could remove the stent by drawing it.However, he found the outer coil of the stent got untied/unraveled and stretched.A section of the device did not remain inside the patient.Updates on (b)(6).When the physician attempted to remove the stent for placing a new stent, he felt it was caught at the upper part of the renal pelvis.After all, he could remove the stent by drawing it.However, he found the wire guide in the coil broke and the outer coil of the stent got untied/unraveled and stretched.A section of the device did not remain inside the patient.Updates on (b)(6)." however, he found the wire guide in the coil broke " "however, he found the wire guide in the stent broke" when the physician attempted to remove the stent for placing a new stent, he felt it was caught at the upper part of the renal pelvis.After all, he could remove the stent by drawing it.However, he found the wire guide in the stent broke and the outer coil of the stent got untied/unraveled and stretched.A section of the device did not remain inside the patient.Updates on (b)(6).A section of the device did not remain inside the patient.After the removal of the stent, a ureteral catheter was inserted from the bladder side for rp (retrograde pyelography), but a contrast medium seemed leaked.The physician looked for the ureteric orifice again, but he could not do that because the surface of the bladder was uneven due to the neurogenic bladder.Then, the physician gave up the plan to place a stent.He kept the patient in stent-free condition.However, nephrostomy was performed for controlling drainage since the patient developed hydronephrosis.The patient is still hospitalized.Contrast radiography was performed, but the parts just under upj (ureteropelvic junction) were totally unseen.For this reason, the condition is not clear now.Ct and contrast radiography are scheduled.After them, the treatment plan will be decided.
 
Manufacturer Narrative
510 (k) number: k063742.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).1.Device evaluation: 1 x rms-060026-rof lot#: c1438372 was returned to cirl for a lab evaluation.It was returned used and not in its original packaging.2.Lab evaluation: the device involved in the complaint was evaluated in laboratory on 17th of january 2019.In summary the following results were observed in the lab evaluation.The stent was found to be unravelled and encrusted along the pigtail.3.Image review: n/a.4.Documents review: a review of the manufacturing records for rms-060026-r device of lot number: c1438372 did not reveal any discrepancies that could have contributed to the issue.There is no evidence to suggest that this issue affects the entire lot#: c1438372; upon review of complaints this failure mode has not occurred previously with this lot#: c1438372.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 (tyvek pouched) 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 (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, ifu0020-15, 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.¿ there is not sufficient evidence to suggest that the user did not follow the ifu.5.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 cause could be attributed to the patient¿s anatomy, if it was highly tortuous or if the stent became caught on a stricture.It was noted the implanted date was on (b)(6) 2018 and the removal date was on (b)(6) 2018, which is over 8 months indwelling period, which is within the recommended indwelling period as per the instructions for use, ifu0020-15, which accompanies this device.Additionally the instructions for use 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¿.As per additional information received, the patient was not checked regularly as the patient did not present herself to attend regular clinic visits as she was not suffering from any ill effects.When the physician was removing the stent, he felt it was caught at the upper part of the renal pelvis.He felt additional force was required to remove the stent.As the removed stent exhibited encrustation, it is likely the stent became imbedded in tissue growth over time and this may have impeded removal of the stent.The excessive force that was applied to remove the stent would have contributed to the stretching and unravelling of the stent.It may be noted that according to the instructions for use, ifu0020-15, in step 7 the user is instructed that ¿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.¿ 6.Summary: complaint is confirmed as the failure was verified in the laboratory.As per physician¿s comments provided in the additional information, the patient¿s condition has deteriorated as a result of the patient¿s condition and anatomy.Patient outcome does not relate to product¿s quality.
 
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Brand Name
RESONANCE STENT SET
Type of Device
FAD STENT, URETERAL
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
MDR Report Key8266520
MDR Text Key133724804
Report Number3001845648-2019-00030
Device Sequence Number1
Product Code FAD
UDI-Device Identifier10827002341118
UDI-Public(01)10827002341118(17)210104(10)C1438372
Combination Product (y/n)N
PMA/PMN Number
K063742
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 02/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/04/2021
Device Model NumberG34111
Device Catalogue NumberRMS-060026-R
Device Lot NumberC1438372
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/16/2019
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/25/2018
Event Location Hospital
Date Manufacturer Received12/26/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age50 YR
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