MAUDE Adverse Event Report: COOK INC SOF-FLEX MULTI-LENGTH URETERAL STENT SET

Catalog Number 039500-8-20

Device Problem Material Separation (1562)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(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 area representative reported he received a call from the user facility about a pediatric stent breaking in half while they were removing it.The surgeon was retrieving the stent and it broke in half but they were able to retrieve the remaining portion of the stent.Additional patient, device and event details have been requested.No additional information has been provided at the time of this report.

Manufacturer Narrative

Investigation ¿ evaluation: a visual inspection and dimensional verification of the returned device was conducted.In addition, a review of complaint history, the device history record, drawings, instructions for use, manufacturing instructions, quality control data, and specifications was performed.One used multi length ureteral stent rpn 039500-8-20 was received.Only the stent was returned.The stent was received in two segments.Dimensional verification confirmed device is a 20 cm stent.The proximal segment consisted of the coil and 1.5 cm of the stent body.The distal segment consisted of coil and 6.5 cm of the stent body.The distal coil has a black discolored appearance.The point of separation occurred at the side port and was noted to have ragged edges and mating fractures.Under magnification the proximal segment was observed to have grasper marks on the stent body, cutting into the material.No obvious manufacturing anomalies were identified or confirmed on the returned sample.A review of the device history record found no non-conformances associated with the complaint device lot number.A review of complaint history revealed there have been no other complaints received that have been associated with the complaint device lot number 5925230.The device is shipped with instructions for use (ifu), which states the proper warnings, precautions, and instructions for use.The ifu contains the following precautions: complications of ureteral stent placement are documented in literature.Use of this device should be based upon consideration of risk-benefit factors as they apply to the patient.The sof-flex, lse sof-flex, c-flex, and aq stents must not remain indwelling more than six (6) months.Do not force components during removal or replacement.Carefully remove the components if any resistance is encountered.Improper handling can seriously weaken the stent.Acute bending or overstressing during placement may result in subsequent separation of the stent at the point of stress after prolonged indwelling period.Angulation of the wire guide or stent should be avoided.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.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.There is no information regarding the length of time the ureteral stent had been placed prior to removal.Per the ifu, ¿the sof-flex stent must not remain indwelling more than six (6) months.There is no information regarding any difficulty with removing the device that may have contributed to the device breaking.Per the ifu, ¿do not force components during removal or replacement.Carefully remove the components if any resistance is encountered.¿ there is no information regarding difficulties placing the stent.Per the ifu, ¿improper handling can seriously weaken the stent.Acute bending or overstressing during placement may result in subsequent separation of the stent at the point of stress after a prolonged indwelling period.Angulation of the wire guide or stent should be avoided.Use of a 0-degree scope lens is recommended.Scopes larger than 21.0 french are suggested.¿ there is no information regarding any renal anatomical features that may have contributed to the device breaking.Per the ifu, ¿individual variations of interaction between stents and the urinary system are unpredictable.¿ the stent in this case was able to be removed.However, if the broken section could not be removed, this could potentially cause hydronephrosis (requiring hospitalization) or surgical removal.Based on the provided information a definitive root cause cannot be established at this time.Measures have been initiated to address the reported failure mode.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

Manufacturer Narrative

Additional information received.Patient age, gender and weight, description of event , device information.

Event Description

Male infant with a right ureteropelvic junction obstruction underwent a cystoscopy with stent removal procedure.The sof-flex multi-length ureteral stent broke while removing it.The remaining portion of the stent was retrieved via ureteropyelscopy and graspers.As reported, there have been no adverse effects to the patient due to this occurrence.

• Brand Name: SOF-FLEX MULTI-LENGTH URETERAL STENT SET
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6980700
• MDR Text Key: 90393862
• Report Number: 1820334-2017-03746
• 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: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 039500-8-20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/29/2017
• Initial Date FDA Received: 10/26/2017
• Supplement Dates Manufacturer Received: 10/26/2017; 03/01/2018
• Supplement Dates FDA Received: 02/26/2018; 03/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 MO
• Patient Weight: 8