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 No Consequences Or Impact To Patient (2199)

Event Date 09/28/2020

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Name and address: postal code: (b)(6).Pma/510k # ¿ pre-amendment.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported, while attempting to remove a filiform double pigtail ureteral stent, that had been indwelling 2.5 months, it broke into four pieces.Two of the four pieces were removed with an endoscope and grasper, while two others required the use of a semirigid ureteroscope and nitinol stone basket to remove from the patient's ureter.The removed pieces were found to be severely encrusted.No section of the device remained inside the patient¿s body.No additional patient consequences were reported.Additional information has been requested.At the time of this report, no further information has been provided.

Manufacturer Narrative

Event summary as reported, it was reported, while attempting to remove a filiform double pigtail ureteral stent, that had been indwelling 2.5 months, it broke into four pieces.Two of the four pieces were removed with an endoscope and graspers, while two others required the use of a semirigid urteteroscope and nitinol stone basket to remove from the patient¿s ureter.The removed pieces were found to be severely encrusted.No section of the device remained inside the patient¿s body.No additional adverse effects were reported.Investigation ¿ evaluation a visual inspection of the returned device was conducted.A document-based investigation was also performed including a review of the instructions for use, drawing, and quality control data.The device was returned in 4 segments.There was heavy encrustation on all segments.The distal segment measured 12.2cm, the next segment measured approximately 1cm, the next segment measured approximately 6.1cm, and the proximal segment measured 2.3cm.A review of the device history record (dhr) could not be carried out as the lot number is unknown.A search of the complaint database could not be carried out as the lot number is unknown.Based on the available evidence and that adequate inspection activities have been established, it was concluded that there is no evidence that nonconforming product exists in house or in field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precautions do not force set components during placement, replacement, or removal.Carefully remove the set components if any resistance is encountered.The stent must not remain indwelling more than twelve months.If the patient¿s status permits, the stent may be replaced with a new stent.The included stent is not intended as a permanent indwelling device.Individual variations of interaction between stents and the urinary system are unpredictable.Periodic evaluation via cystoscopic, radiographic, or ultrasonic means is suggested.The stent must be replaced if encrustation hampers drainage.With the limited information provided, the most likely contributing factors of this event is human anatomy and physiology related.These factors potentially lead to the encrustation of the stent which is a known inherent risk of ureteral stents.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.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.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 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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: 10628055
• MDR Text Key: 209839554
• Report Number: 1820334-2020-01808
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 133626
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Date Manufacturer Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention