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 Break (1069); Difficult to Remove (1528); Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2016

Event Type  malfunction  

Manufacturer Narrative

Phone number: (b)(6).Postal code: (b)(6).(b)(4).The event is currently under investigation.

Event Description

It was reported that a (b)(6) male patient underwent a ptcd procedure in early (b)(6) 2016.The biliary drainage catheter was inducted to the target site; however, the inner core could not be withdrawn and it seemed to be stuck inside.The physician tried to pull out the inner core (exerting his strength) when it was found the inner core was broken.The physician had to remove the entire catheter from the patient gingerly and thus, using a new catheter to finish the procedure.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

Manufacturer Narrative

Ptcd acronym for percutaneous transhepatic cholangiography drainage.Investigation - evaluation: a review of the complaint history, drawings, dimensional verification, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, quality control and visual inspection of the returned device was conducted during the investigation.Visual inspection of the returned device verified that the flexible stiffener had become lodged within the catheter and that the proximal end of the stiffener had broken in half just proximal to the point of adhesion.The proximal half of the stiffener was not returned with the product.The distal half of the stiffener remain lodged within the catheter.The source of the adhesion between stiffener and catheter is unknown.However, the location of the adhesion was determined to be a focal point located at about the mid-length along the lumen of the catheter.By cutting the catheter in half to expose the stiffener the adhesion was able to be overcome with application of a large enough tensile force (e.G.Pulling) on the broken end of the stiffener until it broke free of the catheter.The stiffener then passed freely through the catheter with no resistance.Measurements on the catheter inner diameter and stiffener outer diameter indicated that both were under tolerance, however, both materials were determined to be in poor condition and dimensional measurements as a indicator of conformance to specification were unreliable.Both catheter and stiffener passed freely over each other once the focal adhesion separated.A document based investigation evaluation was also performed.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.There was one additional reported complaint for this lot number.As per the instructions for use (ifu): "when inserting a stiffening cannula into a catheter with retention suture, hold suture during cannula insertion to avoid bunching or tangling of suture." based on the information provided and results of the investigation, a definitive root cause could not conclusively be determined.Per the quality engineering risk assessment no further action is required.Monitoring for similar complaints will continue.

• 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: 5993689
• MDR Text Key: 56359337
• Report Number: 1820334-2016-01019
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002094987
• UDI-Public: (01)00827002094987(17)181222(10)6476630
• 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
• Report Date: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2016
• 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: ULT10.2-38-40-P-32S-CLB-RH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2015
• 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 Age: 90 YR
• Patient Weight: 65