MAUDE Adverse Event Report: COOK VANDERGRIFT INC LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION; DXE CATHETER, EMBOLECTOMY

Catalog Number LR-NES001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pericardial Effusion (3271)

Event Date 11/08/2022

Event Type  Injury  

Event Description

As initially reported to customer relations: a lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to non function.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.The ra lead was successfully removed with a spectranetics 13f tightrail sub-c rotating dilator sheath and a spectranetics 13f tightrail (long).The physician used the 13f tightrail (long) and a spectranetics glidelight laser sheath to attempt removal of the rv lead, but progress stalled high in the superior vena cava (svc) region.No hemodynamic changes occurred with the patient during attempted lead removal from a superior approach.A cook medical needle's eye snare was used to attempt removal of the rv lead from a femoral approach; however during the snaring attempt, a pericardial effusion was detected on transesophageal echocardiography (tee).A pericardiocentesis was performed but did not help, so a sternotomy followed, and an rv perforation was discovered.Repair to the perforation was successfully completed.The patient survived the procedure.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable the event is currently under investigation.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available or upon completion of investigation.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.

Event Description

As initially reported to customer relations: a lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to non function.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.The ra lead was successfully removed with a spectranetics 13f tightrail sub-c rotating dilator sheath and a spectranetics 13f tightrail (long).The physician used the 13f tightrail (long) and a spectranetics glidelight laser sheath to attempt removal of the rv lead, but progress stalled high in the superior vena cava (svc) region.No hemodynamic changes occurred with the patient during attempted lead removal from a superior approach.A cook medical needle's eye snare was used to attempt removal of the rv lead from a femoral approach; however during the snaring attempt, a pericardial effusion was detected on transesophageal echocardiography (tee).A pericardiocentesis was performed but did not help, so a sternotomy followed, and an rv perforation was discovered.Repair to the perforation was successfully completed.The patient survived the procedure.

Manufacturer Narrative

The device was not returned for the complaint, therefore a physical investigation could not be performed and the customer's complaint could not be confirmed.The device history record (dhr) was unable to be viewed due to the lot number specific to this complaint was unknown.Per ifu (d00078680 rev003): "catheter/lead removal devices should be used only at institutions with thoracic surgical capabilities.", "catheter/lead removal devices should be used only by physicians knowledgeable in the techniques and devices for catheter/lead removal.", "prior to the procedure, consider the size of the catheter/lead in relation to the size of the lead extraction¿ devices to determine possible incompatibility.", "if selectively removing catheters/leads with the intent to leave one or more chronic catheters/leads implanted intact, the nontargeted catheters/leads must be subsequently tested to ensure that they were not damaged or dislodged during the extraction procedure.", "do not use excessive force to grasp and pull large portions of doubled-over lead/catheter into the 12 fr or 16 fr sheath, as it could become lodged, preventing further movement of the sheaths or snare(s).", "avoid using the needle¿s eye snare in a manner that could potentially put unwarranted forces and fatigue on the wire.The device is not intended to be excessively twisted and bent while using.Such techniques may cause integrity issues leading to wire breakage within the patient.", "have available an extensive collection of sheaths, locking stylets, stylets to unscrew active fixation leads, snares, and accessory equipment.", "when advancing sheath(s) over the catheter/lead, maintain adequate tension on the catheter/lead (via the basket snare or needle¿s eye snare®) to guide the sheath(s) and prevent damage to vessel walls.", "if excessive scar tissue or calcification prevents safe advancement of sheath(s), consider an alternate approach.", "excessive force with sheath(s) used intravascularly may result in damage to the vascular system requiring surgical repair.", "due to rapidly evolving catheter/lead technology, this device may not be suitable for the removal of all types of catheters/leads.If there are questions or concerns regarding compatibility of this device with particular catheters/leads, contact the catheter/lead manufacturer." "potential adverse events related to the procedure of intravascular extraction of catheters/leads include (listed in order of increasing potential effect): dislodging or damaging nontargeted catheter/lead, chest wall hematoma, thrombosis, arrhythmias, acute bacteremia, acute hypotension, pneumothorax, stroke, migrating fragment from catheter/object, pulmonary embolism, laceration or tearing of vascular structures or the myocardium, hemopericardium/pericardial effusion, cardiac tamponade, hemothorax, cardiac arrest, death", "clinical experience in the removal of leads has identified several considerations for lead removal techniques using superior or femoral approaches.Physicians highly experienced with lead removal techniques have suggested the following considerations for removal of leads, catheters, or other indwelling objects.", "upon removal from package, inspect the product to ensure no damage has occurred." 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 NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION
• Type of Device: DXE CATHETER, EMBOLECTOMY
• Manufacturer (Section D): COOK VANDERGRIFT INC; 1186 montgomery lane; vandergrift PA 15690
• Manufacturer (Section G): COOK VANDERGRIFT INC; 1186 montgomery lane; vandergrift PA 15690
• Manufacturer Contact: brian johnston ; 1186 montgomery lane; vandergrift, PA 15690 ; 7248458621
• MDR Report Key: 15994815
• MDR Text Key: 305587560
• Report Number: 2522007-2022-00026
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961992
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/15/2023

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-NES001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/16/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/15/2023
• 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
• Treatment: SPECTRANETICS 13F TIGHTRAIL (LONG); SPECTRANETICS 13F TIGHTRAIL (LONG); SPECTRANETICS 13F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 13F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS LEAD LOCKING DEVICES; SPECTRANETICS LEAD LOCKING DEVICES
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male