MAUDE Adverse Event Report: COOK INC UNKNOWN; FAD STENT, URETERAL

Catalog Number UNKNOWN

Device Problems Break (1069); Material Separation (1562)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 05/15/2017

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 fda provided a voluntary medwatch report which stated, ¿this is regarding a cook medical ureteral stent that was placed in 2017.This patient gets stents replaced every 3 months or so.She came into the urology department in 2017 to have the stents removed and replaced.Both stents were found to be broken in half upon removal with both ureters containing pieces of the retained stent.Another ureteral stent was able to be inserted anyway so that the patient's urinary status was not compromised.A future surgery was scheduled to remove the broken pieces".This report is being filed to capture the reported breakage of the right ureteral stent.Mfr.Report #1820334-2017-02872 has been filed to capture the reported breakage of the left ureteral stent.As reported, pieces of the stents remained in the patient¿s ureters.Surgical intervention is required to retrieve the pieces that remain.

Manufacturer Narrative

No additional device, patient or event information was able to be obtained as the voluntary medwatch report mw5071714 did not provide a user facility or contact to communicate with for additional information.Investigation - evaluation: the actual complaint device (unknown ureteral stent) was not returned for evaluation and no photos have been provided.Without the complaint device, a physical investigation was not able to be completed.A review of instructions for use, quality control data and trends was conducted.The device history record for the complaint device was not able to be reviewed nor was it possible to perform a review of complaint history.The device rpn and lot number were not provided.The universa (ufh) product line has the largest sales of the stent products.Therefore, it is reasonable to assume the ufh product line may be involved with this complaint.For this complaint rpn ufh-622 will be used as the rpn for the investigation and risk assessment.Per the instructions for use (ifu) cautions: 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 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.Individual variations of interaction between stents and the urinary system are unpredictable.Periodic evaluation via cystoscopic, radiographic, or ultrasonic means is suggested.There is no evidence presented that points to specific failures with current manufacturing or quality controls that may have contributed to this incident.Some factors that may affect the durability and integrity of in-vivo stents include the indwelling environment, user technique during implantation and removal, shipping, and handling prior to implantation.A definitive root cause cannot be established at this time.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: UNKNOWN
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6864855
• MDR Text Key: 86125589
• Report Number: 1820334-2017-02873
• 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: other
• Type of Report: Initial,Followup
• Report Date: 03/01/2018

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/05/2017
• Initial Date FDA Received: 09/14/2017
• Supplement Dates Manufacturer Received: 02/01/2018
• Supplement Dates FDA Received: 03/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention