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

Model Number N/A

Device Problem Material Separation (1562)

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

Event Date 11/24/2015

Event Type  Injury  

Manufacturer Narrative

Lot # is unknown as not provided by reporter.(b)(4).The event is currently under investigation.Lot # is unknown as not provided by reporter.(b)(4).The event is currently under investigation.

Event Description

The stent was needing to be changed.As the physician was removing the device, it broke apart into three pieces.All three pieces were successfully retrieved by the physician.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

A review of complaint history, drawing, instructions for use (ifu), manufacturing instructions, quality control (qc) and a visual inspection of the device was conducted during the investigation.Patent/event info states: initial report states "stent broke apart as the surgeon removed it from the patient.It was only in the patient for 4 months." additional information received (b)(6) 2015 states: the stent was needing to be changed and broke into three pieces while being removed from the patient.All three pieces were successfully retrieved by the physician.No lot # was provided, but the used device was returned for evaluation separated into 4 pieces.Device was examined under magnification.It appeared that all fractures occurred at the location of sideports.There was a small amount of crystallized urine (possibly encrustation) attached to the stent.Fibers of unknown origin were also found attached to the stent.The distal portion of one pigtail was broken off and was not included with the returned product.The customer stated "all three pieces were successfully retrieved by the physician." assuming one of the four pieces came out with the original pull, that probably means the physician removed three additional pieces and sent them back for our evaluation.The location of the distal portion of the pigtail (approximately 2cm) is unknown.The provided precautions "complications of ureteral stent placement are documented.Use of this device should be based upon consideration of risk-benefit factors as they apply to each patient.Informed consent should be obtained to maximize patient compliance with follow-up procedures." and, "do not force components during removal or replacement.Carefully remove the set components if any resistance is encountered." and, "individual variations of interaction between stents and the urinary system are unpredictable." based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Separation is sometimes the result of heavy encrustation and the patient's body chemistry, although in this case, only minimal encrustation was observed.Without additional information, a definitive root cause cannot be established.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• 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
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 5299185
• MDR Text Key: 33582949
• Report Number: 1820334-2015-00866
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 133626
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/24/2015
• Event Location: Hospital
• Date Manufacturer Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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