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 Great Vessel Perforation (2152)

Event Type  Injury  

Event Description

Reported by the district manager on behalf of the customer via phone call - as the customer was manipulating the snare trying to extract a pace maker or fibular the snare somehow tore the patients superior vena cava vein.

Manufacturer Narrative

Pma/510(k): k961992.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

Reported by the district manager on behalf of the customer via phone call - as the customer was manipulating the snare trying to extract a pace maker or fibular the snare somehow tore the patients superior vena cava vein.

Manufacturer Narrative

Blank fields on this form indicated the information is unknown, unchanged, or unavailable.G5 - pma/510(k): k961992.A device was not returned on this complaint, therefore a physical investigation could not be performed and the customer's complaint could not be confirmed other than by customer's testimony.The complaint/event that was entered and reported into trackwise: "snare tore the patients svc vein." the complaint information states: "as the customer was manipulating the snare trying to extract a pace maker or fibular the snare somehow tore the patients svc vein." the device history record (dhr) could not be reviewed because the lot was 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 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: 15673461
• MDR Text Key: 302423986
• Report Number: 2522007-2022-00023
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/09/2023

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/26/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/09/2023
• 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
• Patient Outcome(s): Other