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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK VASCULAR INC LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION; DXE CATHETER, EMBOLECTOMY
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COOK VASCULAR INC LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION; DXE CATHETER, EMBOLECTOMY Back to Search Results
Catalog Number LR-NES001
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Great Vessel Perforation (2152)
Event Date 02/09/2024
Event Type  Injury  
Event Description
As initially reported to customer relations: a 37-year-old female patient underwent a lead extraction procedure in which the lead extraction needle's eye femoral snare and workstation, g26517, was used.While the physician was pulling the lead out it, the lead went through the atrial appendage causing it to tear the atrial appendage.The lead was tangled in the snare and the physician had to cut the snare.The patient required open chest repair where the lead tore the atrial appendage.
 
Manufacturer Narrative
Lank fields on this form indicated 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.D2b ¿ product code: drxe.G5 ¿ pma/510(k): 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 37-year-old female patient underwent a lead extraction procedure in which the lead extraction needle's eye femoral snare and workstation, g26517, was used.While the physician was pulling the lead out it, the lead went through the atrial appendage causing it to tear the atrial appendage.The lead was tangled in the snare and the physician had to cut the snare.The patient required open chest repair where the lead tore the atrial appendage.
 
Manufacturer Narrative
The device was not returned for the complaint; therefore, a physical investigation could not be performed, and the customer's complaint was acknowledged, but could not be confirmed, other than by the customer's testimony.The complaint/event that was entered and reported within trackwise: "atrial appendage tore." per complaint entry: "a 37-year-old female patient underwent a lead extraction procedure in which the lead extraction needle's eye femoral snare and workstation, g26517, was used.While the physician was pulling the lead out it, the lead went through the atrial appendage causing it to tear the atrial appendage.The lead was tangled in the snare and the physician had to cut the snare.The patient required open chest repair where the lead tore the atrial appendage." the device history record (dhr) was unable to be viewed due to the lot number specific to this complaint was unknown.This complaint mode is being monitored, tracked and trended per the cvi post market surveillance and complaint handling processes.A risk assessment will be performed and documented in the complaint summary tab in trackwise.G5 ¿ pma/510(k): k961992 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.
 
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Brand Name
LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION
Type of Device
DXE CATHETER, EMBOLECTOMY
Manufacturer (Section D)
COOK VASCULAR INC
1186 montgomery lane
vandergrift PA 15690
Manufacturer (Section G)
COOK VANDERGRIFT INC
1186 montgomery lane
vandergrift PA 15690
Manufacturer Contact
timothy vogel
1186 montgomery lane
vandergrift, PA 15690
7248458621
MDR Report Key18783750
MDR Text Key336294404
Report Number2522007-2024-00005
Device Sequence Number1
Product Code DXE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
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 NumberLR-NES001
Device Lot NumberUNKNOWN
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/26/2024
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 Number1
Patient Outcome(s) Other; Other;
Patient Age37 YR
Patient SexFemale
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