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

Model Number G15146

Device Problem Device Damaged by Another Device (2915)

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

Event Date 08/29/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Pma/510k #: pre-amendment.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported, during an unspecified procedure using a filiform double pigtail ureteral stent set, while attempting to adjust the stent in situ with forceps they "took a large chunk off the stent".No known adverse events have been reported as a result of the alleged malfunction.Additional details have been requested regarding the patient and event.At this time no additional information has been provided.

Event Description

Additional event information received on 18sep2019: the procedure being completed was a stent exchange and ureteroscopy.The "chunks" of stent were removed from the bladder using reusable forceps.Once the pieces of the stent that come off were retrieved, the procedure was completed by leaving the stent within the patient as planned.

Manufacturer Narrative

D11: karl storz flexible ureteroscope and reusable forceps.Investigation-evaluation: a review of the device history record, the instructions for use, manufacturing instructions, and quality control data were conducted during the investigation.The complaint device was not returned and a sample from the same lot was not available for inspection as an alternative due to the entire lot already being shipped to customers.A review of the device history record found no non-conformances related to the reported failure mode.As there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.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.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.Angulation of the wire guide or stent should be avoided.Use of a 0-degree scope lens is recommended.Scopes larger than 21.0 french are suggested.The complaint device was not returned and a sample from the same lot was not available for inspection as an alternative due to the entire lot already being shipped to customers.The device history record, complaint history and quality control review did not provide evidence to support that the device was manufactured out of specification or to suggest items in the lot or similar devices in the field or in house are nonconforming.The complaint was confirmed based on customer testimony.The cause of the complaint or contributing factors could not be established at this time.The cause of the complaint could not be established.The risk file was reviewed and it was concluded that risk mitigation was recommended, however risk mitigation activities were already implemented.The changes were implemented after the complaint stent was manufactured.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 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: 9070382
• MDR Text Key: 158996751
• Report Number: 1820334-2019-02316
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00827002151468
• UDI-Public: (01)00827002151468(17)200719(10)8077968
• 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

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: 07/19/2020
• Device Model Number: G15146
• Device Catalogue Number: 133626
• Device Lot Number: 8077968
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/05/2019
• Initial Date FDA Received: 09/16/2019
• Supplement Dates Manufacturer Received: 09/18/2019
• Supplement Dates FDA Received: 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1