MAUDE Adverse Event Report: COOK INC SINGLE LUMEN DISTAL AORTIC PRESSURE MONITORING SET; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number N/A

Device Problem Crack (1135)

Patient Problems Hematoma (1884); Blood Loss (2597)

Event Date 08/02/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

It was reported that an art line bled from the insertion site and the patient developed a hematoma.The bedside nurse noticed that these events occurred with the art line which was inserted in axilla in late july.The line was removed in the beginning of august.Once removed the line was noted to be cracked (~ 1cm from catheter hub).The patient's condition was not provided.

Manufacturer Narrative

(b)(4).Investigation - evaluation: a review of the complaint history, manufacturing instructions, and quality control of the device was conducted during the investigation.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was 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.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 quality engineering risk assessment no further action is required.

Event Description

It was reported that an art line bled from the insertion site and the patient developed a hematoma.The bedside nurse noticed that these events occurred with the art line which was inserted in axilla in late (b)(6).The line was removed in the beginning of (b)(6).Once removed the line was noted to be cracked (approx.1cm from catheter hub).The patient's condition was not provided.

Manufacturer Narrative

Investigation - evaluation: a review of the complaint history, manufacturing instructions, quality control and visual inspection of the device was conducted during the investigation.The returned device was examined; one kink was found in the tubing of the catheter approximately 13mm from the hub.The kink appears to be at 90 degrees to the tubings' longest dimension.One of the suture wings has a crack.There was two splits on either side of the kink that were observed using a microscope.The tip was visually inspected and appeared to be damage free.A document based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.The lot number of the device is not known; accordingly a review of the device history record could not be conducted.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 quality engineering risk assessment no further action is required.

• Brand Name: SINGLE LUMEN DISTAL AORTIC PRESSURE MONITORING SET
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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: 5943475
• MDR Text Key: 54459768
• Report Number: 1820334-2016-00927
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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-PMS-501J-DAP-PKG
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2016
• Initial Date FDA Received: 09/12/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/05/2016; 04/12/2017
• 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): Other