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

Model Number G15146

Device Problem Material Separation (1562)

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

Event Date 01/20/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Occupation: non-healthcare professional.Pma/510k: exempt, pre-amendment.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It is reported that while preparing for a procedure using storz ureteroscope to place a filiform double pigtail ureteral stent set, the physician found that part of the pigtail was missing.The issue with this device was discovered prior to making contact with the patient and the device was not used.The procedure was completed with a second filiform double pigtail ureteral stent set.The patient experienced no adverse effects as a result of this alleged product malfunction.The patient's post-procedure outcome is reported to be "well".

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, the device history record, and quality control data.The customer returned one opened package labeled with part number 133626 and lot number 9215563 for investigation.Visual examination confirmed the tether has been pulled out of the stent prior to return.The suture is separated at the knot.The proximal coil is missing from the stent and was not returned.The point of separation occurred 27.8cm from the distal coil.Closer examination of the separated end shows cut striations on the edge with white debris covering the area.It is noted the point of separation did not occur at a side port.Under magnification, the point of separation had an angle cut with jagged striations on the edges.A review of the device history records showed there are no non-conformances that would have caused or contributed to the reported failure mode.A review of complaint history revealed this is the only complaint that has been associated with the complaint device lot number 9215563.The complaint device was returned with the proximal coil missing from the stent.The point of separation occurred 27.8cm from the distal coil.The separation point was viewed under magnification and the point of separation had an angle cut with jagged striations on the edges.The tether of the stent was returned and was separated at the knot indicating it had been removed from the stent.It is likely the stent got damaged when the tether was removed prior to use.The cause of the complaint is likely an unintended user error when the user was removing the tether.Measures have been initiated to address this failure mode.The appropriate internal 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

No new information received since the last report was submitted.

• 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: 8325710
• MDR Text Key: 136284613
• Report Number: 1820334-2019-00360
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00827002151468
• UDI-Public: (01)00827002151468(17)211005(10)9215563
• 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
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2021
• Device Model Number: G15146
• Device Catalogue Number: 133626
• Device Lot Number: 9215563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Date Manufacturer Received: 02/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STORZ URETEROSCOPE
• Patient Age: 32 YR
• Patient Weight: 75