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

Catalog Number LR-NES002

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

Patient Problems Death (1802); Cardiac Tamponade (2226)

Event Type  Injury  

Manufacturer Narrative

Product code: dxe.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

As reported in literature finding, "the medical records of patients who underwent tle (transvenous lead extraction procedures) via the femoral approach utilizing the nes from may 2014 to june 2019 in peking university people¿s hospital were retrospectively reviewed.Major complications including death occurred in nine patients (1.9%), of whom eight developed cardiac tamponade.Among these eight patients emergency pericardiocentesis followed by rescue surgical repair if necessary was successful in 6 (75.0% and failed in 2 (25.0%).¿ this report is intended to capture patient #8 of the 9 sited in this excerpt.While undergoing a transvenous lead extraction procedures using the cook needle¿s eye snare (lr-nes002), patient #8 experienced a cardiac tamponade which required pericardiocentesis and surgical repair.However, the literature finding indicated that the patient did not recover from this event and expired due to the complication.Additional reports will be filed to capture each remaining patient adverse events sited in this article.

Event Description

As reported in literature finding, "the medical records of patients who underwent tle (tranvenous lead extraction procedures) via the femoral approach utilizing the nes from may 2014 to june 2019 in peking university people¿s hospital were retrospectively reviewed.Major complications including death occurred in nine patients (1.9%), of whom eight developed cardiac tamponade.Among these eight patients emergency pericardiocentesis followed by rescue surgical repair if necessary was successful in 6 (75.0% and failed in 2 (25.0%).¿ this report is intended to capture patient #8 of the 9 sited in this excerpt.While undergoing a transvenous lead extraction procedures using the cook needle¿s eye snare (lr-nes002), patient #8 experienced a cardiac tamponade which required pericardiocentesis and surgical repair.However, the literature finding indicated that the patient did not recover from this event and expired due to the complication.Additional reports will be filed to capture each remaining patient adverse events sited in this article.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.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: no lr-nes devices were returned to cvi, therefore a physical investigation could not be performed.The complaint/event that was entered into trackwise: "xuebin li artilce_china_cccform patient#8 of 9-major complications post procedure and full recovered".As reported in literature finding, "the medical records of patients who underwent tle (tranvenous lead extraction procedures) via the femoral approach utilizing the nes from may 2014 to june 2019 in peking university people¿s hospital were retrospectively reviewed.Major complications including death occurred in nine patients (1.9%), of whom eight developed cardiac tamponade.Among these eight patients emergency pericardiocentesis followed by rescue surgical repair if necessary was successful in 6 (75.0% and failed in 2 (25.0%).¿ this report is intended to capture patient #8 of the 9 sited in this excerpt.While undergoing a transvenous lead extraction procedures using the cook needle¿s eye snare (lr-nes002), patient #8 experienced a cardiac tamponade which required pericardiocentesis and surgical repair.However, the literature finding indicated that the patient did not recover from this event and expired due to the complication.Additional reports will be filed to capture each remaining patient adverse events sited in this article.The quality assurance department reviewed the provided article.The device history record (dhr) could not be reviewed due to the unknown lot.A manufacturing failure/defect of the device could not be confirmed with the information provided.Adverse physiological response is a know failure mode of this device.This complaint will be monitored and trended through the cvi complaint handling and the post market surveillance processes.A risk assessment will be performed via qera 200617.1 and documented in the complaint summary of trackwise.Per ifu ((b)(4) rev 002): "potential adverse events: 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.".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: EMBOLECTOMY CATHETER
• Manufacturer (Section D): COOK VANDERGRIFT INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 9565561
• MDR Text Key: 174192867
• Report Number: 2522007-2020-00009
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 10/20/2020

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: 12/10/2019
• Initial Date FDA Received: 01/08/2020
• Supplement Dates Manufacturer Received: 12/10/2019
• Supplement Dates FDA Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 68 YR