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 Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Pma/510k # preamendment occupation = non-healthcare professional , unknown 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, prior to an unknown procedure the user opened a filiform double pigtail ureteral stent set to find the tip of the stent was broken.The device did not make contact with the patient.No adverse effects were reported.Additional information has been requested.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, 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 08jul2021 that was inadvertently not reported in our initial mdr: as reported, the tether was still attached to the stent when the package was opened.The user opened the package and detected the tip of stent was split, and slightly pulled the stent and it separated into two pieces.Another same type device was used to complete the procedure.

Manufacturer Narrative

Event summary: as reported, prior to an unknown procedure the user opened a filiform double pigtail ureteral stent set to find the tip of the stent was broken.The tether was still attached to the stent when the package was opened.The user opened the package and detected the tip of stent was split, and slightly pulled the stent and it separated into two pieces.Another same type device was used to complete the procedure.The device did not make contact with the patient.No adverse effects were reported.Investigation - evaluation: reviews of the complaint history, device history record, instructions for use, and quality control procedures and a visual inspection of the device were conducted during the investigation.One stent was received in an opened outer package.The tether not returned.The stent was returned in two segments.The smaller segment was comprised of the pigtail and measured 5cm in length when stretched.The longer segment comprising the remainder of the stent measured 27.7cm in length from the pigtail to the point of separation.A document-based investigation evaluation was performed by cook.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.A review of relevant manufacturing documents was conducted.No gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is provided with instructions for use which state, ¿upon removal from the package, inspect the product to ensure no damage has occurred.¿ based on the available information, cook has concluded that a cause for this event could not be established.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.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.

Event Description

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

• 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: 12148158
• MDR Text Key: 265842221
• Report Number: 1820334-2021-01739
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002151465
• UDI-Public: (01)10827002151465(17)231130(10)13593106
• 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: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 133626
• Device Lot Number: 13593106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Date Manufacturer Received: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1