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

Model Number N/A

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 09/29/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

It was reported on (b)(6) 2016 a stent was implanted during a ureteroscopy lithotripsy for a patient who had ureteral calculus.Upon scheduled removal of the stent on (b)(6) 2016 by ureteroscope the physician noted the stent was broken inside the patient at the location of 25 cm and 13 cm.Additional procedure was performed on (b)(6) 2016 by ureteroscope and the detached portion of the stent was successfully removed.A section of the device did not remain inside the patient's body.

Manufacturer Narrative

(b)(4).A review of the complaint history, device history record and quality control was conducted during the investigation.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined; however it is possible that user technique and/or patient physiology contributed to this event.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

Event Description

It was reported on (b)(6) 2016 a stent was implanted during a ureteroscopy lithotripsy for a patient who had ureteral calculus.Upon scheduled removal of the stent on (b)(6) 2016 by ureteroscope the physician noted the stent was broken inside the patient at the location of 25cm and 13cm.Additional procedure was performed on (b)(6) 2016 by ureteroscope and the detached portion of the stent was successfully removed.A section of the device did not remain inside the patient¿s body.

• 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
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6061510
• MDR Text Key: 58537881
• Report Number: 1820334-2016-01108
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00827002151468
• UDI-Public: (01)00827002151468(17)190331(10)6856766
• Combination Product (y/n): N
• Reporter Country Code: CN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 133626
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/29/2016
• Initial Date FDA Received: 10/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/20/2016
• Date Device Manufactured: 03/31/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR