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

Catalog Number 133626

Device Problems Fracture (1260); Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 09/22/2020

Event Type  Injury  

Manufacturer Narrative

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

As reported, following a holmium laser lithotripsy procedure, a filiform double pigtail ureteral stent was implanted on (b)(6) 2020.On (b)(6) 2020, the operator extracted the stent which had broken inside of the patient.Some residue was left inside and needed additional intervention for removal.The patient condition is unknown at this time.No information is currently known about the additional intervention required.Additional patient and event details have been requested.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.H3: device has been returned and preliminary evaluation has been performed, however, our investigation is ongoing and device evaluation summary will be included in our follow up report once our investigation has been completed.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.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 was received 10nov2020: there is no plan to remove the small part of the device that was left in the patient after the second procedure.The patient has been discharged and no adverse effect reported.The operator estimated that this small part of the device may have passed out.

Manufacturer Narrative

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.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

The stent was extracted on (b)(6) 2020, not (b)(6) 2020 as reported in our initial report.Additional information was received 29oct2020: the stent was not encrusted.The facility arranged an additional procedure and removed the residue stent by flexible ureteroscope, but there was still a small part left in the patient body.The patient has been discharged.No adverse effect reported so far.Additional patient and event details have been requested.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Event description: as reported, following a holmium laser lithotripsy procedure, a filiform double pigtail ureteral stent was implanted.Approximately five weeks later when stent was being removed from the patient the stent broke inside of the patient.Some residue was left inside the patient and an additional intervention was required to remove the broken section of the stent.The facility arranged an additional procedure and removed the residue stent by flexible ureteroscope, but there was still a small part left in the patients' body.The patient was discharged.There is no plan to remove the small part of the device that was left in the patient after the second procedure.The operator estimated that this small part of the device may have passed out in the patient's urine.Investigation ¿ evaluation.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 (dhr), manufacturing instructions, drawing, specifications, the instructions for use (ifu), and quality control data.One filiform double pigtail ureteral stent was returned for investigation in a used condition.The tether was not returned with the stent.The distal coil was severed from the stent and was not returned.The coil separation occurred 7mm from the first ink mark.The total length of the stent from the first ink mark on the distal end to the last ink mark on the proximal end measured 26cm.Under magnification, the point of separation was confirmed to have occurred at a sideport near the end of the coil.A cut like striation was visible on the severed end.There was no encrustation visible on the stent.No other damage was observed on the stent.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows one other complaint (reference mdr # 1820334-2021-00031) associated with the complaint device lot.Because there were no related non-conformances, adequate inspection activities have been established, and there is objective evidence that the dhr was fully executed, it was concluded that there is no evidence that nonconforming product exists in house or in the field.A review of manufacturing procedures found that current controls for manufacturing and quality controls are in place to assure functionality and device integrity prior to shipping.The instructions for use (ifu), provides the following precautions to the user related to the reported failure mode: "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.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.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." based on the available information, it was not possible to rule out product handling, medical procedure, device failure, or manufacturing related causes as possible contributing factors for this event.The cause for this event could not be established.The risk analysis for this failure mode was reviewed, and it was determined that no actions are required.The appropriate personnel have been notified, and we will continue to monitor 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

There is no new patient or event information to report.

• 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: 10733871
• MDR Text Key: 213181581
• Report Number: 1820334-2020-01936
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002151465
• UDI-Public: (01)10827002151465(17)230616(10)13249613
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/01/2021

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: 06/16/2023
• Device Catalogue Number: 133626
• Device Lot Number: 13249613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 10/26/2020
• Supplement Dates Manufacturer Received: 10/29/2020; 11/10/2020; 05/04/2021
• Supplement Dates FDA Received: 11/04/2020; 12/04/2020; 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR