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

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

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

It was reported by the international customer that, when employing a cook micropuncture triple lumen polyurethane central venous catheter (cvc) set during a central venous catheter insertion, the guide wire which feeds through the needle would get caught on the bevel of the needle when being withdrawn.According to the reporter, this rendered the whole process to be useless, so a new cvc set had to be used, and the patient had another venous puncture site.The customer further reported that a dilator was used prior to the advancement of the catheter, and a scalpel was employed to enlarge the puncture site.The internal placement of the device reportedly varies between the internal jugular and femoral veins.The issue was reportedly resolved when a second central venous catheter set was opened and inserted into a vein at a different site without issue.The circumstances surrounding the usage and handling of the device are not fully known.The device is reportedly not available for return.

Manufacturer Narrative

Event occurred during a pediatric central venous catheter insertion.The reporter stated that no photos, operating reports, x-rays, or scans will be provided.Investigation ¿ evaluation: a review of the complaint history, documentation, specifications, drawings, instructions for use (ifu), manufacturing instructions, and quality control was conducted during the investigation.No issues were found related to the reported complaint.The complaint device was not returned; therefore, no physical examinations could be performed.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.Also, a lot search of the complaint database could not be performed.The ifu states, "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".The ifu also states warnings and precautions that users must be aware of when using the device.Additionally, affixed to the wire guide protective shipping tube is a caution label that pictorially cautions against the reverse process of withdrawing the wire guide in the needle as damage may occur.Based on the information that the wire guide was withdrawn through the provided needle, the root cause of this complaint is procedural related.This complaint was confirmed based on the provided information and investigation.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.

• Brand Name: MICROPUNCTURE TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET
• 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: 6864605
• MDR Text Key: 86117023
• Report Number: 1820334-2017-02899
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• 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: C-UTLM-501J-PED-MP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2017
• 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