MAUDE Adverse Event Report: COOK INC ULTRATHANE RING BILIARY DUCT DRAINAGE CATHETER; GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/13/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).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

The customer reported that, following a biliary drain exchange procedure, it was discovered that the plastic stiffener used to assist with the placement of the ultrathane ring biliary duct drainage catheter was retained in the patient when it should have been removed.Although the stiffener on the inside of the catheter is blue, the customer commented that the cap to the stiffener and the cap to the catheter are both white; furthermore, the customer did not believe the blue color was useful when one attempts to visualize the stiffener from the outside of the device.It is unknown at this time what was done to correct the condition, as this information was not reported.It is also unknown if the device will be returned; as of the date of this report, no device has yet been received.Additional information has been requested from the customer.

Manufacturer Narrative

Pma/510(k) #: preamendment.After further review of the record, it was determined that it should be noted: mw5072533 received on 16oct2017 from and voluntary medwatch form 3500a uf reference: (b)(4) received on 23oct2017.A review of the complaint history, drawings, instructions for use (ifu), manufacturing instructions, and quality control data was conducted during the investigation.The complaint device was not returned; therefore, device failure analysis and physical examination of the device used in this case could not be performed.The stiffener is manufactured at (b)(4).During the manufacturing process, the catheter and the stiffener remain a matched pair.The catheter/stiffener assembly is 100% compared to work order, product labels, drawing and specification.All must match.The customer was concerned that the stiffener could not be visualized from the outside.However, the ifu states "once catheter is in desired location, remove any wire guides, trocars, or stiffeners, allowing the catheter to form its configuration." this suggests that proper configuration of the drainage catheter may have been impaired by the stiffener remaining inside.The stiffeners are 100% visually inspected for the correct placement of the warning label.Every stiffener contains a tyvek warning label i_can_rev 0 that is attached to the proximal end of the stiffener which states "remove after catheter insertion." this warning ( in multiple languages) is attached so that it can be read from the proximal end of the catheter/stiffener assembly as a reminder to the end user.The stiffener has not been returned for evaluation and attempts to gain further information have been unsuccessful.If the product becomes available in the future, the complaint may be reopened for further evaluation.There is also no lot number information to determine any lot related non-conformances or additional complaints from this lot.No notable gaps in production or processing controls have been noted, and risk controls are in place to mitigate the risk of this type of failure.Based on available information, it is feasible to suggest that this failure occurred due use error by the end user and will be trended as did not follow ifu/label.Per the quality engineering risk assessment no further action is required.We will continue to monitor for similar complaints and have notified the appropriate personnel of this event.(b)(4).

• Brand Name: ULTRATHANE RING BILIARY DUCT DRAINAGE CATHETER
• Type of Device: GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6994505
• MDR Text Key: 90837102
• Report Number: 1820334-2017-03648
• Device Sequence Number: 1
• Product Code: GCA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR