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

Model Number G34111

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/23/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported to customer relations: "(b)(6) medical center in (b)(6) had a product failure with our resonance metallic stent yesterday.I do not know the specifics yet.I did not attend the case.I have copied my contact (b)(6) on this email.I have also attached a formal complaint form for (b)(6) to complete as best as she can.Please contact (b)(6) directly with any questions." additional information provided by customer on 28jan2019: "sent what placed and did not coil properly.It was removed and another sent placed." additional information provided by customer on 29jan2019: "yes, both instances of ¿sent¿ is stent and 'sent what placed' should have been 'stent was placed.'.The stent was placed and removed in the same procedure.The stent was placed, noticed that it did not coil correctly and was removed.It was only in place for a moment, maybe two.I was not in the case; however, as it is a ureteral stent, i believe, i would be correct in saying, that the stent was placed in the ureter, left to be exact, and then removed by cystoscopic grasper through the urethra into the bladder and grabbing the stent at the ureteral opening.Then reversing, taking the stent from the ureter into the bladder.They are stored in a climate controlled, positive pressure, operating room under fluorescent lighting, inside a covered cart, still in the cook medical resonance box, in which the stents arrive at our facility." 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/breakage/uncoiling'.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 as follows: importer site contact and address: (b)(4).Importer site establishment registration number: 3005580113 investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

As reported to customer relations: "west valley medical center in caldwell, idaho had a product failure with our resonance metallic stent yesterday.I do not know the specifics yet.I did not attend the case.I have copied my contact keri mckenney on this email.I have also attached a formal complaint form for keri to complete as best as she can.Please contact keri directly with any questions." additional information provided by customer on 28jan2019: "sent what placed and did not coil properly.It was removed and another sent placed." additional information provided by customer on 29jan2019: "yes, both instances of ¿sent¿ is stent and ¿sent what placed¿ should have been ¿stent was placed.¿.The stent was placed and removed in the same procedure.The stent was placed, noticed that it did not coil correctly and was removed.It was only in place for a moment, maybe two.I was not in the case, however, as it is a ureteral stent, i believe, i would be correct in saying, that the stent was placed in the ureter, left to be exact, and then removed by cystoscopic grasper through the urethra into the bladder and grabbing the stent at the ureteral opening.Then reversing, taking the stent from the ureter into the bladder.They are stored in a climate controlled, positive pressure, operating room under florescent lighting, inside a covered cart, still in the cook medical resonance box, in which the stents arrive at our facility." 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/breakage/uncoiling'.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 (b)(4).Importer site establishment registration number: (b)(4).1.Device evaluation: 1 x unit of device rpn: (b)(4) of lot # c1444272 was returned opened and in its¿ original packaging.2.Lab evaluation: the device involved in the complaint was evaluated in the laboratory on 22nd february 2019.In summary the following results were observed in the lab evaluation.One pigtail was found to be out of shape.3.Image review: n/a 4.Documents review including ifu review: prior to distribution (b)(4) 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 (b)(4) of lot number c1444272 did 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 c1444272.In the final quality control produce, it instructs the manufacturing team member to ¿check for kinks or damage along stent length.¿ also to ¿measure pigtail diameter and pigtail distortion as per drawing.Similarly the manufacturing team member is to ¿ensure that the stent curls are opposite as per drawing.¿ the instructions for use, ifu0020-15, which accompanies this device warns of the following ¿improper handling of the stent prior to insertion into the ureter may harm the functionality of the stent.Bent, stretching or any type of improper handling may deform the stent.It is important that the stent is handled with care¿.It may be noted that according to the instructions for use, ifu0020-15, instructs the user: ¿use the introduction catheter to advance the stent through the sheath (fig 2) until the numbered marker corresponding to the stent length being deployed reaches the hub on the sheath (fig 3).At this point the first pigtail will have fully deployed from the sheath.¿ further ¿to prevent further deployment of the stent into the kidney hold the introduction catheter in place and retract the sheath.When the hub of the sheath aligns with the proximal ink mark on the introduction catheter the second pigtail is about to deploy.At this point retract both the sheath and introduction catheter completely (fig.2)¿ the surgeon placed the stent and then it was observed under direct observation and x-ray that the stent did not coil correctly and was removed by cystoscopic grasper through the urethra into the bladder and grabbing the stent at the ureteral opening.Then reversing, taking the stent from the ureter into the bladder.As per additional information received on 29th of january 2019.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 stent becoming over stretched during the preparation stage.It may be noted from the additional information received on 29th of january 2019; they did not report difficulties placing the stent, however when the surgeon placed the stent it was observed under direct observation and x-ray that the stent did not coil correctly and was removed by cystoscopic grasper through the urethra into the bladder and grabbing the stent at the ureteral opening.Then reversing, taking the stent from the ureter into the bladder.6.Summary: complaint is confirmed as the failure was verified in the laboratory.According to the information reported, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for emerging trends.

Event Description

As reported to customer relations: "(b)(6) in (b)(6) had a product failure with our resonance metallic stent yesterday.I do not know the specifics yet.I did not attend the case.I have copied my contact (b)(6) on this email.I have also attached a formal complaint form for (b)(6) to complete as best as she can.Please contact (b)(6) directly with any questions." additional information provided by customer on 28jan2019: "stent what placed and did not coil properly.It was removed and another sent placed." additional information provided by customer on 29jan2019: the stent was placed and removed in the same procedure.The stent was placed, noticed that it did not coil correctly and was removed.It was only in place for a moment, maybe two.I was not in the case, however, as it is a ureteral stent, i believe, i would be correct in saying, that the stent was placed in the ureter, left to be exact, and then removed by cystoscopic grasper through the urethra into the bladder and grabbing the stent at the ureteral opening.Then reversing, taking the stent from the ureter into the bladder.They are stored in a climate controlled, positive pressure, operating room under florescent lighting, inside a covered cart, still in the cook medical resonance box, in which the stents arrive at our facility.".

• Brand Name: RESONANCE STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8350049
• MDR Text Key: 136613496
• Report Number: 3001845648-2019-00067
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002341118
• UDI-Public: (01)10827002341118(17)210119(10)C1444272
• 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: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2021
• Device Model Number: G34111
• Device Catalogue Number: RMS-060026-R
• Device Lot Number: C1444272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/24/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/28/2019
• Initial Date FDA Received: 02/19/2019
• Supplement Dates Manufacturer Received: 01/28/2019; 01/28/2019
• Supplement Dates FDA Received: 03/20/2019; 04/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR