MAUDE Adverse Event Report: COOK INC PERFORMER INTRODUCER; DYB INTRODUCER, CATHETER

Catalog Number RCFW-12.0-38-30-RB

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) number = pre-amendment.Investigation-evaluation: a review of the drawing, instructions for use (ifu), manufacturing instructions, and quality control procedures 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 instruction for use (ifu) which states: "all instruments or catheters used with this product should move freely through the valve and sheath.Damage to the valve/introducer may result when the fit is tight.When inserting, manipulating, or withdrawing a device through an introducer always maintain introducer position.Do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt.Sheath introduction: upon removal from package, ensure the inner diameter (id) of the introducer is appropriate for the maximum diameter of the instrument or catheter to be introduced.Using the side-arm of the valve, flush the introducer by filling the introducer assembly completely with heparinized saline.Flush the dilator with heparinized solution.Insert the dilator completely into the introducer.Using standard seldinger technique, access the target vessel with the appropriate needle.Insert wire into the vessel through the needle, then remove needle, leaving the wire guide in place.Insert dilator/sheath combination over wire guide.Remove wire guide and dilator, aspirate and flush introducer side-arm.Insert appropriately sized device as needed.Sheath removal: insert wire guide at least 10cm past the tip of the sheath.Insert the dilator over the wire into the sheath.Withdraw the sheath and dilator as a unit.Remove the wire guide." based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be established.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during an endovascular aneurysm repair, a performer introducer leaked at the hub.The user reported that the silicone disk does not adjust to wires "like before" and when unspecified lunderquist wires are left inside the device, it leaks blood "drop by drop".A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: PERFORMER INTRODUCER
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 9536268
• MDR Text Key: 176050032
• Report Number: 1820334-2019-03186
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: ES
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RCFW-12.0-38-30-RB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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