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 Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/21/2016

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.(b)(4).The event is currently under investigation.

Event Description

It was reported the joint of catheter was found leaking bile.The catheter was checked and the joint part was found to be cracked.The device was replaced.A section of the device did not remain inside the patients body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Investigation - evaluation : a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, and quality control was conducted during the investigation.The device is shipped with an instruction for use (ifu) that describes the intended use, specific items are addressed such as: "these products are intended for use by physicians trained and experienced in diagnostic and interventional techniques.Standard techniques for placement of percutaneous drainage catheters should be employed.Manipulation of products requires ultrasound, fluoroscopy, or other imaging guidance.When inserting a stiffening cannula into a catheter with retention suture, hold suture during cannula insertion to avoid bunching or angling of suture.A tfe-coated wire guide must be used with ultrathane® catheters.Activate the hydrophilic coating, if present, by wetting the catheter with sterile water or saline.For best results, keep catheter surface wet during placement.Catheters should be irrigated on a routine basis to ensure function.Patients with indwelling drainage catheters should be evaluated routinely to ensure continuous function of the catheter.Traction on the locking suture, if present, should be sufficient to ensure adequate retention of the tip, but should not be overly tight.Verify catheter tip configuration by fluoroscopy.It is recommended to use a wire guide when removing a locking loop catheter.The peel-away® pigtail straightener, if present, is not to be used as a vascular introducer sheath.The potential effects of phthalates on pregnant/nursing women or children have not been fully characterized and there may be concern for reproductive and developmental effects".Investigation of the returned device revealed that the suture was broken and that the catheter was cut at the point where the suture emerged from the catheter.It is reasonable to suggest that the device met forces beyond his design during the placement and manipulation (during the procedure) determined by the user technique, which might have resulted in the malfunction of the device.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the health risk assessment no further action is required.

Event Description

It was reported the joint of catheter was found leaking bile.The catheter was checked and the joint part was found to be cracked.The device was replaced.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the connector cap separated from both the flare of the catheter and the mac-loc, and advanced distally along the catheter shaft.No measurements proved to be out of spec.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Measures have been previously conducted to address this failure mode.We will continue to monitor for similar complaints.Per the health 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: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 6098854
• MDR Text Key: 59737890
• Report Number: 1820334-2016-01310
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002094970
• UDI-Public: (01)00827002094970(17)180608(10)5940315
• Combination Product (y/n): N
• Reporter Country Code: CN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 70