MAUDE Adverse Event Report: COOK INC OPEN-END URETERAL CATHETER; GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 05/02/2017

Event Type  Injury  

Manufacturer Narrative

The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

It was reported that the physician placed an open-end ureteral catheter set prior to total abdominal hysterectomy (tah).After completion of the tah, the ureteral catheter set was removed by another physician.It was noted upon inspection that the right ureteral catheter set was not completely removed.Abdominal ct scan confirmed the retention of a portion of the device.Patient returned to the operating room and retained piece was removed from the ureter by using a cystoscope and an ureteroscope with graspers.Additional information was requested regarding the failure of the device.

Manufacturer Narrative

The user facility reported this event to fda under user facility medwatch report (uf report# (b)(4)) on may 11, 2017.Cook medical received this report from the fda on may 18, 2017 which was not included with the previously submitted report.Investigation - evaluation: a review of dimensional verification, specifications, and quality control data, along with visual inspection of the actual products was conducted during the investigation.As reported, a part of the product remained in the patient which was removed the next day.One catheter was returned separated into two segments.Point of separation occurred 1mm above the 17cm ink band.Area of separation has a pinched and slightly elongated appearance with frayed looking ends on each segment.Point of separation appear to be mating fractures.The material when manipulated remained pliable and did not show any signs of degradation.Material has been pinched and pulled to separation.The second catheter was returned in one piece measuring 69.5 cm in length that is within specified length tolerances.There were no manufacturing anomalies identified on either catheter.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 and device integrity prior to shipping.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.This complaint is confirmed based on the customer's testimony, and a physical evaluation of the returned product.Based on the provided information a definitive root cause cannot be established or reported at this time, but is likely related to compression of the stent with an instrument accompanied with longitudinal stress causing the stent to tear and separate during removal.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: OPEN-END URETERAL CATHETER
• Type of Device: GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6604199
• MDR Text Key: 76397604
• Report Number: 1820334-2017-01045
• Device Sequence Number: 1
• Product Code: GBL
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2017
• 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: 020116
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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: 48 YR