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 Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Code Available (3191)

Event Date 09/15/2017

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, a few hours following the conclusion of the biliary tube placement using a ultrathane mac-loc locking loop biliary drainage catheter, the patient's caregiver reported that the catheter was leaking bile from the plastic end cap.The catheter was ultimately exchanged as a result.A physician examined the device and noted the crack to clearly be at the junction of the end cap of the catheter and the actual catheter portion of the device.The catheter was cut to facilitate its removal and exchange, but the catheter and end cap were both saved for return.The circumstances surrounding the usage and handling of the device prior to the leakage were not reported.The device has been received for evaluation; however, the investigation is still pending.

Manufacturer Narrative

Investigation - evaluation: a review of documentation, manufacturing instructions, drawings, instructions for use (ifu), quality control data, and visual inspection of the returned device was conducted during the investigation.The catheter was returned cut distal to the mac-loc, with the mac-loc in the locked position.Two threads were visible between the mac-loc and cap, which is greater than the number indicated in the manufacturing instructions.No cracks were observed in the mac-loc or cap when observed under 20x magnification.Marks consistent with forceps or hemostats were present on the cap, presumably from trying to tighten the cap to prevent leakage.The catheter was free to twist in the proximal assembly, but did not pull out.The cap could not be untwisted from the mac-loc.Hemostats were used to occlude the catheter in order to pressurize the proximal assembly.Water leaked out of the hub starting at a pressure of 8psi.The lot number was not provided, so a search of any nonconformances is applicable and additional complaints associated with this lot could not be performed.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 results, a definitive root cause cannot be determined.We will notify the appropriate personnel and continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• 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: 6910655
• MDR Text Key: 88019608
• Report Number: 1820334-2017-03434
• Device Sequence Number: 1
• Product Code: GCA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• 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: ULT14.0-38-40-P-32S-CLB-RH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/27/2017
• 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