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

Catalog Number LR-NES002

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 07/24/2019

Event Type  Injury  

Manufacturer Narrative

Product code: dxe.Concomitant medical devices: cook liberator® beacon® tip locking stylet (lr-ofa01), cook one-tie¿ compression coil (lr-ote-n), cook evolution® rl controlled-rotation dilator sheath set (lr-evn- 9.0-rl), cook evolution® shortie controlled-rotation dilator sheath set (lr-evn-sh-11.0-rl), cook bulldog¿ lead extender (lr-led01).Pma/510(k): k961992.(b)(4).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.

Event Description

It was reported that this complaint involves a study patient enrolled in the (b)(6) clinical study (protocol (b)(6), patient (b)(6)).During the lead extraction procedure and the use of the needle¿s eye snare, the patient developed a pericardial effusion.The ra lead was removed first using only the needle's eye snare (lr-nes002)."counterclockwise torsion was applied to unscrew the lead.The lead was then retracted and removed in it's entirety through the right femoral vein sheath." the right ventricle lead extraction was attempted next.Using a regular soft stylet the tip and active fixation mechanism was retracted."with gentle traction, the lead was retracted from the right ventricle and pulled back until it was noted to get caught on adhesions in the right atrium.Further pulling was not performed.The lead was cut at the end and the suture sleeve was removed.A liberator® beacon® tip locking stylet (lr-ofa01) was advanced onto the lead until resistance was met.The locking stylet was deployed achieving adequate lock.The outer insulation was secured using a one-tie¿ compression coil (lr-ote-n) tied to the end of the lead.Next, a 9fr evolution® rl controlled-rotation dilator sheath (lr-evn- 9.0-rl) sheath was advanced over the lead and stylet.Due to proximal resistance, an 11f cook evolution® shortie controlled-rotation dilator sheath set (lr-evn-sh-11.0-rl) was used first to free intravenous adhesions in the distal vasculature.The evolution® sheath was advanced along the lead & by applying counter traction under fluoroscopic guidance.The lead was very adherent to the right atrium.It was noted to unravel near the tip and almost broke.Snaring from the femoral approach was attempted.It could not be snared.The lead broke at the distal tip and a small approx.0.5 cm fragment was retained in the right atrium.The rest of the lead was removed." shortly after the blood pressure was noted to be dropping and the pericardial effusion was noted.No further adverse events have been reported and the patient has exited the study as scheduled.The patient recovered following a pericardiocentesis.The patient was discharged from the hospital two days post-procedure.No further adverse events have been reported.The event was not assessed by the physician as due to a device deficiency.

Manufacturer Narrative

Additional information: h6- ec method code desc - 1: device not returned (4114).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).H10- added summary of investigation.Investigation / evaluation: per complaint: "this complaint involves a study patient enrolled in the release: transvenous lead removal using the cook evolution® lead extraction system post-market clinical study (protocol: (b)(4), patient: (b)(6).During the lead extraction procedure during the use of the needle¿s eye snare, the patient developed a pericardial effusion.The site assessed this as causally related to both the device (needle¿s eye snare) and the procedure.The rational for both assessments was that it happened during the procedure and during the use of the device.However, additional information obtained by email from the monitor reveals ¿for the first lead removed, ra lead, only the needle eye snare was used as indicated.During the rv lead extraction, first the superior approach with the liberator and rl devices were attempted.The rv lead was then snared from the femoral approach and the following was noted: ¿it could not be snared.The lead broke at the distal tip and a small approx.0.5 cm fragment was retained in the ra.The rest of the lead was removed.Shortly after, it was noted that the bp was dropping.Fluoro of the lateral hear border in the lap position did not show good motion.A tee was then performed and a pericardial effusion was noted.¿" "the patient recovered following a pericardiocentesis.The patient was discharged from the hospital two days post-procedure." "from op-note, the ra lead was removed first using only the needle's eye snare."counterclockwise torsion was applied to unscrew the lead.The lead was then retracted and removed in it's entirety through the right femoral vein sheath." the rv lead extraction was attempted next.Using a regular soft stylet the tip and active fixation mechanism was retracted."with gentle traction, the lead was retracted from the rv and pulled back until it was noted to get caught on adhesions in the ra.Further pulling was not performed.The lead was cut at the end and the suture sleeve was removed.An ez lead locking stylet was advanced onto the lead until resistance was met.The locking stylet was deployed achieving adequate lock.The outer insulation was secured using a one-tie compression coil tied to the end of the lead.Next, a 9f cooke evolution rl sheath was advanced over the lead and stylet.Due to proximal resistance, a 11f cook shortie was used first to free intravenous adhesions in the distal vasculature.The evolution sheath was advanced along the lead & by applying counter traction under fluoroscopic guidance.The lead was very adherent to the ra.It was noted to unravel near the tip and almost break.Snaring from the femoral approach was attempted.It could not be snared.The lead broke at the distal tip and a small approx.0.5 c, fragment was retained in the ra.The rest of the lead was removed." shortly after the bp was noted to be dropping and the pericardial effusion was noted." device was not returned to cvi, therefore a physical investigation could not be performed.The device history record (dhr) could not be reviewed due to the lot of the device was unknown.Per ifu (d00078680 rev002): "catheter / lead removal devices should be used only by physicians knowledgeable in the techniques and devices for catheter / lead removal" , "have available an extensive collection of sheaths, locking stylets, stylets to unscrew active fixation leads, snares, and accessory equipment." , "potential adverse events.Hemopericardium / pericardial effusion", "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.

Event Description

This complaint involves a study patient enrolled in the release: transvenous lead removal using the cook evolution® lead extraction system post-market clinical study (protocol: (b)(4), patient: (b)(6).During the lead extraction procedure during the use of the needle¿s eye snare, the patient developed a pericardial effusion.The site assessed this as causally related to both the device (needle¿s eye snare) and the procedure.The rational for both assessments was that it happened during the procedure and during the use of the device.However, additional information obtained by email from the monitor reveals ¿for the first lead removed, ra lead, only the needle eye snare was used as indicated.During the rv lead extraction, first the superior approach with the liberator and rl devices were attempted.The rv lead was then snared from the femoral approach and the following was noted: ¿it could not be snared.The lead broke at the distal tip and a small approx.0.5 cm fragment was retained in the ra.The rest of the lead was removed.Shortly after, it was noted that the bp was dropping.Fluoro of the lateral hear border in the lap position did not show good motion.A tee was then performed and a pericardial effusion was noted.¿ the event was not assessed by the md as due to a device deficiency.The patient recovered following a pericardiocentesis.The patient was discharged from the hospital two days post-procedure.No further aes have been reported.On (b)(6) 2019 update: from op-note, the ra lead was removed first using only the needle's eye snare."counterclockwise torsion was applied to unscrew the lead.The lead was then retracted and removed in it's entirety through the right femoral vein sheath." the rv lead extraction was attempted next.Using a regular soft stylet the tip and active fixation mechanism was retracted."with gentle traction, the lead was retracted from the rv and pulled back until it was noted to get caught on adhesions in the ra.Further pulling was not performed.The lead was cut at the end and the suture sleeve was removed.An ez lead locking stylet was advanced onto the lead until resistance was met.The locking stylet was deployed achieving adequate lock.The outer insulation was secured using a one-tie compression coil tied to the end of the lead.Next, a 9f cooke evolution rl sheath was advanced over the lead and stylet.Due to proximal resistance, a 11f cook shortie was used first to free intravenous adhesions in the distal vasculature.The evolution sheath was advanced along the lead & by applying counter traction under fluoroscopic guidance.The lead was very adherent to the ra.It was noted to unravel near the tip and almost break.Snaring from the femoral approach was attempted.It could not be snared.The lead broke at the distal tip and a small approx.0.5 c, fragment was retained in the ra.The rest of the lead was removed." shortly after the bp was noted to be dropping and the pericardial effusion was noted.No further aes have been reported and the patient has exited the study as scheduled.(b)(6).

• 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
• MDR Report Key: 8946442
• MDR Text Key: 160893584
• Report Number: 2522007-2019-00007
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• PMA/PMN Number: K961992
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Type of Report: Initial,Followup
• Report Date: 08/27/2020

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-NES002
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/05/2019
• Initial Date FDA Received: 08/29/2019
• Supplement Dates Manufacturer Received: 08/05/2019
• Supplement Dates FDA Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 116