MAUDE Adverse Event Report: COOK, INC. PERFORMER INTRODUCER; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Device Problem Material Separation (1562)

Patient Problem Foreign body, removal of (2365)

Event Type  Injury  

Event Description

Pulled all of our 6fr, 7fr, 8fr dialysis sheaths because the sheaths separates (breaks in to 2 pieces) from the distal part during fistulogram procedures, which we have to snare the distal part of the sheath out of the patient arm.We have stopped ordering these sheaths until the issue is fixed.The patient outcome will be determined once the completed complaint form is received.

Manufacturer Narrative

(b)(4).Still under investigation.

• Brand Name: PERFORMER INTRODUCER
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: rita harden, director ; 750 daniels way; p.o. box 489; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4187729
• MDR Text Key: 18796627
• Report Number: 1820334-2014-00538
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date: 09/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/02/2014
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/26/2014
• Initial Date FDA Received: 10/14/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention