MAUDE Adverse Event Report: COOK INC TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER TRAY; DQY CATHETER, PERCUTANEOUS

Model Number N/A

Device Problem Partial Blockage (1065)

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

Event Date 10/08/2017

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

The customer reported that, when the operator attempted to withdraw the wire guide from the triple lumen polyurethane central venous catheter on (b)(6) 2017, the wire guide would not withdraw.The threading of the catheter over the wire and the vessel dilation portions of the procedure which occurred earlier were uneventful.However, the wire could not be removed from the catheter thereafter.Several attempts were made to reposition the line, but none were successful.The catheter was eventually removed from the patient, and the wire could not even be removed at that point.The customer characterized the wire as having a lot of "drag." the device has been received for evaluation; however, as of the date of this report, the investigation is still pending.

Manufacturer Narrative

User facility report number: (b)(4).Investigation ¿ evaluation: a review of the dimensional verification, complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the returned device was conducted during the investigation, and no issues were found related to the reported issue.Additionally, the complaint device was returned to cook to assist with the complaint investigation.A device failure analysis was performed on the returned device.A visual inspection and functional evaluation were performed as a part of this investigation.The visual inspection of the returned device confirmed that the wire guide was returned inserted backwards into the white no.1 hub of the catheter.The stiff end of the wire was exiting the distal end of the cvc.The customer confirmed they put the wire in backwards after the case while trouble shooting the issue.The wire guide had a 90 degree bend just outside of the hub.The wire was advanced and retracted slightly and resistance was observed.The wire was removed from the proximal end of the device, and bio-matter, assumed to be dried blood, was observed to be surrounding the wire.Upon rinsing the bio-matter, the wire was re-advanced through the lumen of the device and with much less resistance noted.The functional evaluation of the device revealed that the distal weld connection located at the ¿j¿ tip end was broken, resulting in coil elongation without mandrill protrusion.Coil elongation began measuring from the apex of the curve approximately 3.4cm, having overall length of approximately 1.5cm.The wire was inadvertently kinked in the elongated section during investigation.Bio matter was noticed in the most distal side port of the triple lumen cvc.Destructive testing of the wire guide was executed to determine location of solder and/or weld breakage.During the investigation of the wire, the distal weld was removed in an effort to determine if the weld connection separated from the safety wire/coil or if the solder connection separated from the safety wire mandrill connection.Destructive testing discovered that the weld connection separated from the safety wire at the specified ¿j¿ end.During additional testing of the catheter, the number one lumen was successfully flushed with water.No obstructions were found in the number one lumen (main lumen).The shaft of the catheter was dissected lengthwise, and no visible disruptions in the main lumen were observed.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.Based on this information, it was determined that the product in this case was built to specification, and there is no evidence to suggest this failure was manufacturing related.The device is shipped with instruction for use (ifu) which includes the following instructions and cautions: 4.Slide safe-t-j® wire guide straightener (positioned on distal tip of wire guide) over ¿j¿ portion of wire guide.Pass straightened wire guide through needle; advance wire guide 5-10 cm into vessel.If straight wire is used, always advance soft, flexible end through needle hub and into vessel.If resistance is encountered during wire guide insertion, do not force wire guide.Withdrawal of wire guide through needle should be avoided; breakage may result.8.Introduce the central venous catheter over wire guide.While maintaining wire guide position, advance catheter into vessel with a gentle twisting motion.(fig.1) note: do not advance catheter tip beyond distal tip of wire guide.Always have wire guide leading during catheter placement.Verify catheter tip position using radiography or appropriate technology.In order to guarantee extra pericardial location, the catheter tip should be located above the svc-ra junction, within the lower 1/3 of the svc.Every effort must be made to ascertain proper tip position in order to prevent erosion or perforation of the central venous system and to ensure proper delivery of infusates.9.After catheter is in position, remove wire guide.(fig.2) venous blood should be easily aspirated.The ifu also states that ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.Per the quality engineering risk assessment no further action is required.The reported event is occurring within the expected occurrence and severity levels.We will continue to monitor for similar complaints.

Event Description

Additional information: pediatric physician was placing a right triple lumen intrajugular (ij) line.This mdr is being reported based on investigation of the wire guide, it was discovered the distal weld connection located at the ¿j¿ tip end was broken, resulting in coil elongation.

• Brand Name: TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER TRAY
• Type of Device: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 7014711
• MDR Text Key: 91935057
• Report Number: 1820334-2017-03933
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00827002269453
• UDI-Public: (01)00827002269453(17)191201(10)7917679
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2017
• 2 Devices were Involved in the Event: 1 2

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: C-UTLMY-501J-RSC-CCT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2017
• Initial Date FDA Received: 11/09/2017
• Supplement Dates Manufacturer Received: 12/22/2017
• Supplement Dates FDA Received: 12/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1