MAUDE Adverse Event Report: COOK INC ROSS MODIFIED COLAPINTO DESIGN TRANSSEPTAL NEEDLE; DRC TROCAR

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Matthew g.Gipson, md., et al: intravascular us-guided portal vein access: improved procedural metrics during tips creation j vase lnterv radio! 2016; 27:1140-1147.The above referenced journal article alleged that a patient, identified as patient (n=2) in our analysis of the article, underwent transjugular intrahepatic portosystemic shunt (tips) creation with the use of image guidance.Tips intervention within 3 months was necessary in this patient, n=2, for hemodynamic failure.The study population was divided into three patient groups determined by planned primary pv access technique chosen based on operator preference: fluoroscopic guidance with or without c02 portography, transhepatic or transsplenic marker wire guidance, and intravascular us guidance.The article reported that "a retrospective review of procedures performed between july 2012 an october 2014 was conducted, after approval by the institutional review board, to identify consecutive patients undergoing primary transjugular intrahepatic porto-systemic shunt (tips) procedures" while using a haskal transjugular intrahepatic portal access set."all three guidance techniques used for tps creation have been previously described.A 16-gauge colapinto needle (cook) was used for all cases.When a severe angle between the hepatic vein and portal vein (pv) was discovered, the curve of the colapinto needle was increased, or a 65.5-cm, 21-gauge chiba biopsy needle (cook) was used through the colapinto needle to accentuate the bend of the needle.Ten patients (14.7%) experienced procedural complications resulting in escalation of care (table 3).These included a subcapsular hematoma requiring transfusion (n = 1) medwatch 1820334-2016-00982 , hemoperitoneum requiring transfusion (n = 2) medwatch 1820334-2016-00989 , postprocedural transient bile leak (n = 1), contrast agent-induced renal failure (n = 1) , and stent malposition (n = 3) medwatch 1820334-2016-01023.Stent malposition occurred during deployment of a second stent in all three cases, and contributed to minor neck hematomas in two patients that resulted from intervention to reposition the stent.One additional hemoperitoneum without a need for transfusion was recognized based on drainage of bloody ascetic fluid.Procedural complications that escalated care were found to be similar between groups.Two patients died before discharge, both of whom had emergent procedures for bleeding, with acute model for end-stage liver disease scores of 30 and 31.A third patient, the only patient to undergo tips creation after liver transplantation, died within 30 days of the procedure as a result of liver failure despite subsequent intentional tips closure.The 30-day mortality rate was 44% and was not statistically different between groups.Tips intervention within 3 months was necessary in three patients and included intentional tips closure (n=1) and dual (ie, "double=barrel") tips creation (n=2) for hemodynamic failure (n=1) and clinical failure (n=1) with continued bleeding".Clinical opinion of the event: "this observation was made known through an article.It is unknown if the patient experienced any adverse events.".Based on the available information it is reasonable to suggest that the leading cause to this event might be associated with a pre-existing patient condition or the medical procedure.

Manufacturer Narrative

(b)(4).Investigation - evaluation: a review of the complaint history, documentation, instructions for use (ifu), trends and quality control 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.The lot number of the device is not known; accordingly a review of the device history record could not be conducted.The device is shipped with an instruction for use (ifu) that describes the intended use, precautions and potential adverse events, which includes intraperitoneal hemorrhage.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: ROSS MODIFIED COLAPINTO DESIGN TRANSSEPTAL NEEDLE
• Type of Device: DRC TROCAR
• 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: 5969594
• MDR Text Key: 55379826
• Report Number: 1820334-2016-00989
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: RM-16-50.5-COLAPINTO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2017
• 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