MAUDE Adverse Event Report: COOK INC SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET; FAD STENT, URETERAL

Catalog Number 039514

Device Problem Material Separation (1562)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 09/21/2017

Event Type  Injury  

Manufacturer Narrative

Product lot# - the customer reports the lot number is either of 6534797 or 7327998.(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

The user facility reported that in (b)(6) 2017, a sof-flex pediatric double pigtail ureteral stent was placed in the urinary duct of an unidentified patient.On (b)(6) 2017, a stent exchange was performed and the user noticed the stent had become darker/black.During removal under cystoscopic control, the stent broke off.The broken end was sticking out into the bladder, so it was pulled carefully.The stent broke off again.All pieces were successfully removed.A new sof-flex pediatric double pigtail ureteral stent was placed and the procedure completed.There was no part of the device left inside the patient¿s body.No additional procedures were required due to this occurrence.The patient did not experience any adverse effects or consequences.Additional patient, device and event information has been requested but a response has not yet been received.

Manufacturer Narrative

Investigation ¿ evaluation: investigation methods used include dimensional verification, review of the instructions for use (ifu), specifications, and a visual inspection of the returned device.One used sof-flex pediatric double pigtail ureteral stent was returned in three (3) separate pieces for investigation.The packaging was not returned.Distal segment - coil with 5cm of stent body attached.2cm of the stent body was not discolored, remaining segment was discolored.The coil width measured 18mm and had a relaxed appearance.There was heavy encrustation covering the coil.The stent material beneath the encrustation is cracked and split.The coil appeared brittle and kinked easily in three locations.The point of separation occurred at a side port.Middle segment - 1cm of the stent body had black discoloration with light encrustation.Both points of separation on this segment occurred at a side port with a ragged appearance on the edges.Proximal segment ¿ the coil with approximately 9cm of stent body attached.The stent kinks easily 3.3cm from the end of the coil.Various sections had black discoloration.The length of all returned segments measuring from distal to proximal ink bands between coils measured approximately 14cm.Both points of separation had mating fractures indicating there were no missing pieces.There is no indication that a design or process related failure mode contributed to this event.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.A review of the device history records was performed for the two lot numbers provided.Neither device history record contained any non-conformances related to the reported failure mode.A review of complaint history for lot numbers 6534797 and 7327998 revealed there have been no other complaints received against either of these lots.Based on the customer's reported statement, the stent was implanted in (b)(6) 2017 and removed (b)(6) 2017.The date in march that the stent was implanted and/or the exact number of days of stent implantation is not known.The instruction for use (ifu) supplied with the stent set provides the following information: individual variations of interaction between stent and the urinary system are unpredictable".Periodic evaluation via cystoscope, radiographic, or ultrasonic means is suggested.The stent must be replaced if encrustation hampers drainage.Polyurethane, sof-flex, and lse sof-flex stents must not remain indwelling more than 6 months.Stents are not intended as permanent indwelling devices.Do not force components during removal or replacement.It is likely the stent reached or exceeded maximum implantation duration of six months.Based on the evidence presented by the sample and the information provided by the supporting documentation, procedural and clinical factors appear to have impacted on the event as reported.Based on the information provided, a definitive root cause cannot be established.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The case was investigated again based on additional information provided by the customer on 20mar2019: the information provided confirmed the implant date for the device was (b)(6) 2017, six months and 14 days prior to its removal.This indwelling time exceeds the maximum time recommended for this device as noted in the instructions for use (ifu).The investigation concluded that the patients anatomy contributed to the complaint.A risk analysis was carried out that concluded additional risk mitigation was not required.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Additional information was provided by the customer on 20mar2019.The information verified that the device implant date was (b)(6) 2017.A computerized tomography (ct) scan at a later date (unspecified time interval) showed that the stent had separated.The doctor commented 'the patient's anatomy was stenosed at where the stent was separated, so i suppose the stenosis affected and stretched the stent to lead to separate.The separation was not due to the stent defect'.

• Brand Name: SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6915217
• MDR Text Key: 88203170
• Report Number: 1820334-2017-03421
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 039514
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention