MAUDE Adverse Event Report: COOK INC. NEEDLE'S EYE SNARE; CATHETER, EMBOLECTOMY

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Low Blood Pressure/ Hypotension (1914); Paresis (1998); Perforation (2001)

Event Type  Death  

Event Description

Three (3) shock leads needed to be extracted, 2 single coils and 1 dual coil lead.Dwell time of sprint quatro secure 9months, 1 riata.Sprint quatro came out with simple traction.Placed lld ez in both leads and tried to extract using cook dilator first and the tightrail 13f.It was impossible to free the lead until the curve to svc.Finally could free the single coil lead couldn't remove via subclavian.Couldn't free the dual coil because of externalisation of the inner conductors.Tightrail got stuck, but removed safely.Then used the needle's eye snare to extract the single coil from below.1 min after the extraction a sudden drop in bp was noticed with stable hr.Rescue balloon was deployed.Tee didn't show a tear or perforation.Physician decided to make a pulmonary angio, which showed massive emboli.Patient condition deteriorated and resuscitation was started.After 1 hour patient was stabilized but decided to install ecmo.It was reported the patient died (b)(6) 2020.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: NEEDLE'S EYE SNARE
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): COOK INC.
• MDR Report Key: 17535977
• MDR Text Key: 321042689
• Report Number: MW5142869
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1