MAUDE Adverse Event Report: COOK VASCULAR INC. LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem Foreign body, removal of (2365)

Event Date 05/15/2015

Event Type  Injury  

Event Description

During a lead extraction procedure on a (b)(6) patient,the locking stylet slipped back into the inside diameter of the lead before deployment.This action caused the liberator stylet to lock approximately 3 inches proximal to the distal tip of the lead, pulling it apart during extraction where it was locked.Ultimately, the lead broke at the place where the liberator stylet was locked (3 inches proximal to the distal tip).The remainder of the lead was successfully retrieved using a goose-neck snare.The reported states the liberator stylet has an outside diameter of.015.The inner diameter of the lead is.023.The differences in diameters may have caused the liberator to slip before deployment.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not experience any adverse effect nor require any additional procedures due to this occurrence.

Manufacturer Narrative

(b)(4).Event is currently under investigation.

Manufacturer Narrative

Common device name: dqx, wire, guide, catheter.(b)(4).According to information provided this device will not be returned for evaluation.In addition, neither photos nor the device's lot number was returned, so a full investigation cannot be performed.Based on comments received, the locking stylet slipped within the lead, possibly due to a difference in the od of the liberator and the id of the lead.There is no evidence that the device did not deploy properly, nor is there evidence of manufacturing nonconformity.Based on the information provided, it appears that the device deployed properly and did not fracture during the procedure.The root cause of the complaint is unknown.

Event Description

During a lead extraction procedure on a (b)(6) male patient, the locking stylet slipped back into the inside diameter of the lead before deployment.This action caused the cook liberator stylet to lock approximately 3 inches proximal to the distal tip of the lead, pulling it apart during extraction where it was locked.Ultimately, the lead broke at the place where the cook liberator stylet was locked (3 inches proximal to the distal tip).The remainder of the lead was successfully retrieved using a goose-neck snare.The reporter states the cook liberator stylet has an outside diameter of.015.The inner diameter of the lead is.023.The differences in diameters may have caused the liberator to slip before deployment.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not experience any adverse effects nor require any additional procedures due to this occurrence.

• Brand Name: LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET
• Manufacturer (Section D): COOK VASCULAR INC.; vandergrift PA 15690
• Manufacturer Contact: larry pool ; 750 daniels way; p.o. box 489; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 4845049
• MDR Text Key: 5868505
• Report Number: 1820334-2015-00359
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970690
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2015
• 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: LR-OFA01
• Other Device ID Number: SEE FIELD H10.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/15/2015
• Event Location: Hospital
• Date Manufacturer Received: 05/18/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR