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

Catalog Number LR-NES001

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 03/30/2020

Event Type  malfunction  

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

It was reported that the cook needle's eye snare (lr-nes001) was already broken in the package.However, upon the manufacturer's receiving of the device on 18 august 2020 it was discovered that the device had clearly made patient contact and the nature of the breakage requires an manufacturers incident report be filed.Further information has been requested from the customer, however a response has not yet been forthcoming.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: h6- ec method code desc - 1: testing of actual/suspected device (10).H6- ec method code desc - 2: historical data analysis (4109).H6- ec results code desc - 1: fracture problem (3252).H6- ec conclusions code desc - 1: cause not established (4315).H10- added summary of investigation.Investigation-evaluation: a used lr-nes001 device was returned to cvi for investigation.The complaint/event entered into trackwise: "the snare was already broken in the package." the quality assurance department performed an investigation on the returned device.Visually the device was indeed broken on the snare, however the device was used.There was blood present on the device and an unknown brownish liquid within the side valve port tube.There was also a white substance near the snare, which could possibly be dried saline.At the end of the inner sheath, it appears slightly bent and the outer sheath has a few knick marks on the end.Under magnification, it appears that the device has an unknown substance present.The break has a smooth break that appears slightly concave.When looking at the inner wires, there appears to be dried blood and an unknown white/yellow substance.The device history record (dhr), including the quality inspection and manufacturing records were reviewed.There were no signs to indicate that this device was manufactured out of specification or shipped nonconforming.This lot number has not been previously returned on a complaint.This complaint type will continue to be monitored, tracked and trended per cvi's complaint handling and post market surveillance processes.A risk assessment will be performed via qera 200617.2 and documented in the complaint summary tab in trackwise.Capa 306710 is open for the failure mode of lasso broke.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

It was reported that the cook needle's eye snare (lr-nes001) was already broken in the package.However, upon the manufacturer's receiving of the device on (b)(6)2020 it was discovered that the device had clearly made patient contact and the nature of the breakage required an manufacturers incident report be filed.Further information was requested from the customer, however no response has been received.

• 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: 10531346
• MDR Text Key: 218679331
• Report Number: 2522007-2020-00017
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: LR-NES001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 09/14/2020
• Supplement Dates Manufacturer Received: 03/31/2020
• Supplement Dates FDA Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other