MAUDE Adverse Event Report: COOK INC FILIFORM DOUBLE PIGTAIL URETERAL STENT SET; FAD STENT, URETERAL

Catalog Number 133626

Device Problem Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/08/2020

Event Type  Injury  

Manufacturer Narrative

Pma/ 510k #: pre-amendment.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported, after laparoscopic pyeloplasty, the patient went to the hospital for a follow-up exam.In the exam, encrustation was found on the filiform double pigtail ureteral stent.A procedure was performed to remove the stent and the stent broke in the procedure.A section of the stent remained in the patient's body.Two weeks later, a percutaneous renal extubation was performed to remove the rest of the device.No additional patient consequences were reported.Additional information has been requested regarding the patient and the event.At the time of this report, no further information has been provided.

Event Description

No new patient or event information since the last report was submitted.

Manufacturer Narrative

Investigation ¿ evaluation.It was reported, after laparoscopic pyeloplasty, the patient went to the hospital for a follow-up exam two months after stent placement.In the exam, encrustation was found on the filiform double pigtail ureteral stent.At that time, the stent was still providing sufficient drainage.The patient was not pregnant or taking calcium supplements and had not previously had kidney stones.The patient¿s anatomy was reported to have a narrow ureteral junction.A procedure was performed to remove the stent using wolf foreign body forceps and the stent broke in the procedure.A section of the stent remained in the patient's body.Two weeks later, a percutaneous renal extubation was performed to remove the rest of the device.The patient has recovered from the event.A visual inspection of the returned device was conducted.A document-based investigation was also performed including a review of complaint history, device history record, drawing, the instructions for use, and quality control data.The complainant returned one filiform double pigtail ureteral stent set for investigation.Visual examination confirmed the stent only was returned in used condition inside a plastic bag.Stent was separated into three segments along with a significant amount of loose encrustation.The distal segment was approximately 14.4 long from the base of the distal coil to the point of separation; point of separation occurred approximately 3cm from the base of the proximal coil.Encrustation has formed around the stent body at the base of the distal coil; distal coil was intact.Various degrees of encrustation was visible in some of the side ports and at the point of separation.Severe degradation penetrated through the material on the distal coil approximately 2cm from the distal end of the coil.Due to severe encrustation the distal stent segment would not wire using a.038¿ wire guide.The proximal coil segment was separated into two segments; one segment includes 3cm of the coil with 3.3cm of stent body attached.There was a moderate amount of encrustation visible on the outside of the stent and inside one side port.The tip of the proximal coil was separated approximately 1.5cm from the end of the coil.Significant degradation was observed on both segments of the proximal coil and stent body; degradation had penetrated completely through the material in some areas of the coil.Coil separation occurred in an area where material was severely degraded.Both proximal segments wired successfully using a.038¿ wire guide.The combined length of both proximal and distal segments measure approximately 17.4cm, approximately 8.6cm of stent body is missing and was not returned.A review of the device history record (dhr) found no non-conformances related to the reported failure mode.The raw material lot used to manufacture the stent was reviewed and no non conformance were found to be recorded.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: "do not force set components during placement, replacement, or removal.Carefully remove the set 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 a prolonged indwelling period.The stent must not remain indwelling mot than 12 months.Individual variations of interaction between stents and the urinary system are unpredictable.Periodic evaluation via cystoscope, radiographic, or ultrasonic means is suggested.Stent must be replaced if encrustation hampers drainage.A clinical review of the complaint was inconclusive but identified that possible contributing factors for this event include human anatomy, medical procedure, device compatibility, user technique, and device failure.Based on the information available the conclusion of the complaint is the cause cannot be established.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.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.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.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 received on 15apr2020: the stent was indwelling for 2 months before the encrustation was identified, at that time the stent was still providing sufficient drainage.The patient was not pregnant or taking calcium supplements and had not previously had kidney stones.The patients anatomy was reported have a narrow ureteral junction.The stent separation occurred whilst attempting to remove it percutaneously from the kidney using wolf foreign body forceps.The patient has recovered from the event.

• Brand Name: FILIFORM DOUBLE PIGTAIL URETERAL STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9961724
• MDR Text Key: 188199975
• Report Number: 1820334-2020-00819
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002151465
• UDI-Public: (01)10827002151465(17)220910(10)10002643
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 05/27/2020

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: 09/10/2022
• Device Catalogue Number: 133626
• Device Lot Number: 10002643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2020
• Initial Date Manufacturer Received: 04/09/2020
• Initial Date FDA Received: 04/15/2020
• Supplement Dates Manufacturer Received: 04/15/2020; 05/22/2020
• Supplement Dates FDA Received: 04/17/2020; 05/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention