MAUDE Adverse Event Report: COOK INC BANDER URETERAL DIVERSION STENT SET; GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Material Separation (1562)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 02/15/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow up report will be send upon conclusion.

Event Description

It was reported by the user facility that on (b)(6) 2017, a male patient underwent a robotic assisted laparoscopic cystoprostatectomy & ilio conduit conversion created.The patient was discharged to go home once the procedure was complete however, on (b)(6) 2017 the patient called the urologist to inform them that the stent had fell out.The patient had brought the part that fell out back to the urologist and noted that the curved part at the bottom of the stent was not attached.Per ct scan the urologist confirmed the curved part had retained in the kidney.A procedure was scheduled on an unknown date in (b)(6) to remove the curved part of the stent and was unsuccessful with no harm to the patient.The urologist then went back in on (b)(6) 2017 to do an antigrade assisted right ureteroscopy with retrieval of retained right ureteral stent.The urologist was successful in retrieving the stent portion with no harm to the patient.No further information was provided.

Manufacturer Narrative

Correction(s): (b)(4).Investigation summary: a review of complaint history, device history record, documentation, specification, visual inspection and quality control data was conducted during the investigation.A review of the device history record found no other non-conformances and a review of complaint history search found no other complaints associated with the complaint device lot number.The product was returned for investigation.One partial coil was returned, and there was no identifying part or lot number.The outside diameter of the tubing measured within specification.Under magnification striation marks observed on point of separation; coil has been severed behind the fifth sideport.This device appears to have been cut by an instrument of undetermined origin.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.A review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Based on the provided information, inspection of returned product and the investigation, a definitive root cause cannot be established or reported at this time.However, it is possible that user technique contributed to this event.Per the quality engineering risk assessment no further action is required.We will notify the appropriate personnel and continue to monitor for similar complaints.

• Brand Name: BANDER URETERAL DIVERSION STENT SET
• Type of Device: GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
• 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: 6460058
• MDR Text Key: 71708092
• Report Number: 1820334-2017-00607
• Device Sequence Number: 1
• Product Code: GBL
• UDI-Device Identifier: 00827002169951
• UDI-Public: (01)00827002169951(17)180707(10)6013999
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 025228
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2015
• 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: 72 YR