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

Model Number	N/A
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/30/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that a (b)(6) male patient had a stent placed in early (b)(6) 2016.After several months, the stent was found to be surrounded by calculus; therefore, the stent was removed in late (b)(6) 2016.During the procedure, the near-side stent was removed, but the distal part failed to remove.The surgeon operated using the pneumatic lithotripsy under ureteroscope.The user took an ureteroscopy to take out the detached part of the stent eventually.A section of the device did not remain inside the patient's body.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, dimensional verification, device history record, documentation, specifications and visual inspection of the returned device was conducted during the investigation.The visual inspection of the returned device reported one stent was received in one piece; no cracks or separation were observed on the material.The proximal end of the stent exhibited heavy encrustation covering the entire circumference of the coil starting approximately 1.2cm from the end of the coil.A small piece of encrusted material was loosened and removed from the end of the coil.No obvious manufacturing anomalies were observed on the stent.A document based investigation evaluation was also 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.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
It was reported that a (b)(6) male patient had a stent placed in early (b)(6) 2016.After several months, the stent was found to be surrounded by calculus; therefore, the stent was removed in late (b)(6) 2016.During the procedure, the near-side stent was removed, but the distal part failed to remove.The surgeon operated using the pneumatic lithotripsy under ureteroscope.The user took an ureteroscopy to take out the detached part of the stent eventually.A section of the device did not remain inside the patient¿s body.

• Brand Name: FILIFORM DOUBLE PIGTAIL URETERAL STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6004287
• Report Number: 1820334-2016-01094
• Device Sequence Number: 625055
• Product Code: FAD
• UDI-Device Identifier: 00827002151475
• UDI-Public: (01)00827002151475(17)180622(10)5975644
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2016

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 133628
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/06/2016
• Supplement Report FDA Received Date: 01/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PNEUMATIC LITHOTRIPSY
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR