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

Model Number G15146

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Information (3190)

Event Date 07/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6) pma/510(k) # - preamendment.(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 was reported that prior to use, the user opened the package and checked the integrity of the filiform double pigtail ureteral stent they found out there is a hole at pigtail.Additional information has been requested regarding the patient and the event.At the time of this report, no further information has been provided.

Event Description

It was reported on (b)(6) 2018, the patient was prepped and awaiting a ureteroscopy procedure.The procedure was completed using another same device.The patient did not experience any adverse effect(s) due to this issue.

Manufacturer Narrative

Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document based investigation was also performed.This included a review of complaint history, the device history record, review of drawing, and review of specifications.One package labeled rpn 133626 and label lot 8677617 was received.Stent was returned without the tether; tether was not returned.A tear was observed in the proximal coil 4cm from the end.Tear noted to partially separate coil and is within 1mm of a sideport.The device history record was reviewed, and no related non-conformances occurred during the production of lot number 8677617.A search of complaint records found this is the only complaint associated with lot number 8677617.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually inspected by quality control and no related gaps in production or processing controls were noted.The returned complaint device was found to have a partial tear 4 cm from the end.The tether was not attached to the stent and was not returned.The condition of the returned device missing the tether makes it possible that it was inadvertently damaged during use.Based on the provided information and evaluation of returned device, it appears most likely the stent became inadvertently torn when removing the tether prior to use of the stent.The assigned investigation conclusion is cause traced to user : unintended use error caused or contributed to event.The risk analysis for this failure mode was reviewed, and it was determined that no additional risk mitigating activity 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
• MDR Report Key: 7776578
• MDR Text Key: 116913494
• Report Number: 1820334-2018-02444
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00827002151468
• UDI-Public: (01)00827002151468(17)210320(10)8677617
• 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: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2021
• Device Model Number: G15146
• Device Catalogue Number: 133626
• Device Lot Number: 8677617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• Initial Date Manufacturer Received: 07/19/2018
• Initial Date FDA Received: 08/13/2018
• Supplement Dates Manufacturer Received: 08/13/2018
• Supplement Dates FDA Received: 09/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 60