MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER; GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY

Model Number N/A

Device Problem Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 03/21/2017

Event Type  malfunction  

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

International customer reported that a patient underwent placement of a ultrathane mac-loc locking loop biliary drainage catheter on (b)(6) 2017.The drain was placed with the flexible blue stiffener.The physician attempted to remove the stiffener after establishing the desired pig-tail and met resistance during the removal.The physician pulled "so hard" that the stiffener tore and the guide wire elongated; one-half of the stiffener remained within the catheter.The drain with the retained stiffener fragment remains in clinical use as of the date of this report.There are no reported adverse patient consequences as a result of this retained fragment.The device is currently not available for evaluation, however it will be returned upon the devices' end of useful need explant.

Manufacturer Narrative

(b)(4).A review of drawing, instructions for use, manufacturing instructions, quality control, dimensional verification and visual inspection of the returned device were completed during this investigation.The stiffener that is the subject of this report was not returned.The catheter was returned in a used condition.The catheter was measured and found to be within manufacturing specifications.There is no damage noticed in the catheter.The catheter set is supplied with both a metal stiffener and a flexible stiffener.The flexible nylon radiopaque tubing device was used in this case based upon the customers description of the device.A certain amount of curving and flexing is inherent to the design of a pigtail catheter.A document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The lot number of the device is not known; accordingly a review of the device history record could not be conducted.The device is shipped with an instruction for use (ifu) that describes the intended use; specific items are addressed such as: "once catheter is in desired location, remove any wire guides, trocars, or stiffeners, allowing the catheter to form its configuration.For mac-loc stabilize the mac-loc catheter hub assembly with one hand an pull back on the drawstring to form the distal catheter loop configuration.While maintaining traction on the drawstring, push the locking cam down until a distinct "snap" is felt.The distal loop of the catheter is now locked into position." based on the information provided, examination of the returned device and the results of our investigation, user error caused or contributed to the event.The customer failed to remove the stiffener prior to placing traction on the drawstring.We will continue to monitor for similar complaints.Per the risk assessment no further action is required.

• Brand Name: ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER
• Type of Device: GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY
• 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: 6574993
• MDR Text Key: 75431016
• Report Number: 1820334-2017-00765
• Device Sequence Number: 1
• Product Code: GCA
• Combination Product (y/n): N
• Reporter Country Code: HU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/14/2017

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-40-P-32S-CLB-RH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2017
• Initial Date FDA Received: 05/18/2017
• Supplement Dates Manufacturer Received: 08/07/2017
• Supplement Dates FDA Received: 08/14/2017
• 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: 58 DA