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

Catalog Number LR-OFA01

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Low Blood Pressure/ Hypotension (1914); Injury (2348)

Event Date 08/20/2018

Event Type  Injury  

Manufacturer Narrative

Common name-stylet, catheter, product code-drb.Pma/510k#-k170298.This event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

A lead extraction of an sjm durata icd lead was attempted.The lead was prepped with a liberator locking stylet and a one-tie proximal compression coil.The physician then prepped an 11f evolution rl, g23746.Did not record the lot number.The device was not saved.When he entered the clavicle area (subclavian vein) with the evolution, the lead released from the right ventricle.As he removed the lead the pressure dropped to around 20.At that point the surgeon was called.The chest was opened and the tear in the rv was repaired.The patients ending pressure was 126/81.The patient survived.The physician looked at the distal coil of the lead and he noticed that there was calcific tissue over the entire coil, which he thinks caused the tear.

Event Description

As reported to customer relations: a lead extraction of an sjm durata icd lead was attempted.The lead was prepped with a liberator locking stylet and a one-tie proximal compression coil.He then prepped an 11f evolution rl, g23746.Did not record the lot number.The device was not saved.When he entered the clavicle area (subclavian vein) with the evolution, the lead released from the right ventricle.As he removed the lead the pressure dropped to around 20.At that point the surgeon was called.The chest was opened and the tear in the rv was repaired.The patients ending pressure was 126/81.Dr.(b)(6) looked at the distal coil of the lead and he noticed that there was calcific tissue over the entire coil, which he thinks caused the tear.The evolution did not enter the heart.

Manufacturer Narrative

Additional information: h6- ec method code desc - 1: changed to device not manufactured by reporting manufacturer (4113).H6- ec results code desc - 1: changed to no findings available (3221).H6- ec conclusions code desc - 1: changed to known inherent risk of device (22).Investigation-evaluation: the lr-ofa01 liberator locking stylet was not returned to cvi for investigation.No photos or x-rays were provided.The customer complaint/event that was reported in trackwise; " as reported to customer relations: a lead extraction of an sjm durata icd lead was attempted.The lead was prepped with a liberator locking stylet and a one-tie proximal compression coil.He then prepped an 11f evolution rl, g23746.Did not record the lot number.The device was not saved.When he entered the clavicle area (subclavian vein) with the evolution, the lead released from the right ventricle.As he removed the lead the pressure dropped to around 20.At that point the surgeon was called.The chest was opened and the tear in the rv was repaired.The patients ending pressure was 126/81.Dr.Soto looked at the distal coil of the lead and he noticed that there was calcific tissue over the entire coil, which he thinks caused the tear.The evolution did not enter the heart." the lr-ofa01 liberator locking stylet device was not returned, a physical investigation was not performed therefore a determination if the device was defective is inconclusive.The ifu was reviewed and listed as a potential adverse event is 'laceration or tearing of vascular structures or the myocardium'.There is an incoming inspection pull test of the wires of the devices as part of the quality checks.This complaint event is a known failure mode and will be monitored and captured per the complaint handling and post market processes at cvi.A risk assessment will be completed per qera/risk assessment for this failure mode, reference the complaint summary tab of trackwise for this complaint.A device history record review could not be performed as the lot number is unknown.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 7877119
• MDR Text Key: 120291924
• Report Number: 2522007-2018-00019
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/07/2020

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
• Device Catalogue Number: LR-OFA01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/20/2018
• Initial Date FDA Received: 09/14/2018
• Supplement Dates Manufacturer Received: 08/20/2018
• Supplement Dates FDA Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention