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

Model Number G15146

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pma/510(k) #: 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

It was reported during an unknown procedure when the doctor introduced the filiform double pigtail ureteral stent, it did not work and did not form the curly and then it broke.The reporter stated, ¿possibility of an issue with the device¿.As reported, no additional procedures were required due to this occurrence.There were no adverse effects on the patient.Additional event, device and patient information has been requested but no new information has been provided at the time of this report.

Event Description

Additional information received on 23aug2018.The physician introduced the double j in the patient, the curl in the device was never formed.He tried several times to position the double j.When he pulled out the double j it was already damaged.He put in a new one.He (patient) is fine.

Manufacturer Narrative

Method codes: 4114, device not returned.Conclusion codes: 4135, cause not established.Investigation: evaluation: the complaint device was not returned for an evaluation and no photograph or imaging was provided.Without the complaint device, a device failure analysis was unable to be performed.A document based investigation was conducted including a review of complaint history, the device history record, instructions for use, manufacturing instructions, and quality control data.The device history record was reviewed for lot number: 8421584 and noted there are no conformances that may have caused or contributed to this incident.A review of complaint history records revealed this is the only complaint associated with the complaint device lot number: 8421584.The manufacturing documents were also reviewed.The appropriate inspections were found to be in place for the material used to manufacture the stents and for the finished stents.Based on the available information, the cause of the complaint was not able to be established.Per the quality engineering risk assessment, no additional risk mitigating activity is required at this time.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database 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.

• 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: 7801225
• MDR Text Key: 117852650
• Report Number: 1820334-2018-02557
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00827002151468
• UDI-Public: (01)00827002151468(17)201205(10)8421584
• 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: 09/24/2018

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: 12/05/2020
• Device Model Number: G15146
• Device Catalogue Number: 133626
• Device Lot Number: 8421584
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/08/2018
• Initial Date FDA Received: 08/21/2018
• Supplement Dates Manufacturer Received: 09/21/2018
• Supplement Dates FDA Received: 09/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1