MAUDE Adverse Event Report: COOK VASCULAR INC LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET; DQX WIRE, GUIDE, CATHETER

Catalog Number LR-OFA01

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Excessive Tear Production (2235)

Event Date 05/25/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The physician attempted to remove the arterial pacemaker lead that was implanted 13 years ago.At one point during the extraction the lead was free from the right atrium.At that point a drop in pressure was noted.The surgeon initiated a sternotomy to repair the tear in the right atrium.The tear was repaired.The patient's chest was closed and the rest of the leads were extracted.The patient is reported to be alive and doing well.

Manufacturer Narrative

(b)(4).Investigation/evaluation: during the course of the investigation, a review of the complaint history and instructions for use (ifu) of the product was conducted.Based on information received from the customer, a patient undergoing pacemaker lead extraction experienced a drop in blood pressure following removal of a lead from the right atrium.The tear was repaired by physicians and no further health effects were reported.A locking stylet was used in this procedure and was the closest device to the site of the bleeding.There were no reports of misuse of the device, device failure, or device nonconformity were received.The damage to the cardiac wall is a known complication of the pacemaker lead extraction procedure, which is documented in the ifu for the product.There were no signs that this device malfunctioned or contained a nonconformity.The device was not returned, no images were provided, and no other information about possible device nonconformities was provided.Therefore, a definitive root cause could not be determined.Bleeding can occur if the pacemaker lead was embedded in the cardiac wall such that a portion of the wall or vasculature is removed with the lead.There were no signs that a device nonconformity or misuse lead to this event.We will continue to monitor for similar complaints.Per the quality engineering risk assessment (qera) no further action is required.

Event Description

The physician attempted to remove the arterial pacemaker lead that was implanted 13 years ago.At one point during the extraction the lead was free from the right atrium.At that point a drop in pressure was noted.The surgeon initiated a sternotomy to repair the tear in the right atrium.The tear was repaired.The patient's chest was closed and the rest of the leads were extracted.The patient is reported to be alive and doing well.

Manufacturer Narrative

(b)(4).(additional information provided/updated): investigation/evaluation: during the course of the investigation, a review of the complaint history and instructions for use (ifu) of the product was conducted.Based on information received from the customer, a patient undergoing pacemaker lead extraction experienced a drop in blood pressure following removal of a lead from the right atrium.The tear was repaired by physicians and no further health effects were reported.A locking stylet was used in this procedure and was the closest device to the site of the bleeding.There were no reports of misuse of the device, device failure, or device nonconformity were received.The damage to the cardiac wall is a known complication of the pacemaker lead extraction procedure, which is documented in the ifu for the product.There were no signs that this device malfunctioned or contained a nonconformity.The device was not returned, no images were provided, and no other information about possible device nonconformities was provided.Therefore, a definitive root cause could not be determined.Bleeding can occur if the pacemaker lead was embedded in the cardiac wall such that a portion of the wall or vasculature is removed with the lead.There were no signs that a device nonconformity or misuse lead to this event.We will continue to monitor for similar complaints.Per the quality engineering risk assessment (qera) no further action is required.

Event Description

The physician attempted to remove the arterial pacemaker lead that was implanted 13 years ago.At one point during the extraction the lead was free from the right atrium.At that point a drop in pressure was noted.The surgeon initiated a sternotomy to repair the tear in the right atrium.The tear was repaired.The patient's chest was closed and the rest of the leads were extracted.The patient is reported to be alive and doing well.

• Brand Name: LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET
• Type of Device: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 5726808
• MDR Text Key: 47450878
• Report Number: 1820334-2016-00458
• Device Sequence Number: 1
• Product Code: DXQ
• 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: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: LR-OFA01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/25/2016
• Event Location: Hospital
• Date Manufacturer Received: 05/25/2016
• 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): Life Threatening
• Patient Age: 50 YR