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

Device Problem Break (1069)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Type  Injury  

Event Description

Patient information unk.Removing 4 leads (2 right ventricular (rv), 1 right atrial (ra), 1 left ventricular (lv).Extraction indication unk.A lead extraction procedure commenced to remove 4 leads.The physician successfully removed 3 leads with use of a spectranetics glidelight laser sheath (ra, rv, lv).Another rv lead was present, not accessible from the device pocket area; therefore a laser device could not be utilized to assist in removal of this rv lead.All spectranetics lead extraction devices were removed from the patient, and the physician used a cook medical needle's eye snare to remove the remaining rv lead from the patient's groin.When the lead broke free from the right ventricle during lead removal, the patient's blood pressure dropped.A full sternotomy was performed and a successful repair was made; the patient survived the procedure.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 MEDICAL
• MDR Report Key: 17529658
• MDR Text Key: 321133254
• Report Number: MW5136583
• 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: 01/18/2022

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1