MAUDE Adverse Event Report: MEDTRONIC VASCULAR GOOSE NECK SNARE KIT/CATHETER; CATHETER, EMBOLECTOMY

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/25/2023

Event Type  malfunction  

Event Description

A cardiomems implant procedure was attempted using intra jugular approach.Upon advancing the delivery system to the target location, the guidewire position was lost and subsequent reposition attempts were unsuccessful.The physician attempted to retract and remove the delivery system under fluoroscopy however the sensor became stuck at the distal end of the sheath due to a kink and crimping of the distal end of the sheath and the sensor being slightly untethered.A medtronic goose neck snare was used as an aid but did not result in retrieval.The delivery catheter was then cut and an attempt to exchange the sheath was made but was unsuccessful.A second access site was then made in the right groin and a different snare was used in attempt to retrieve the delivery system but this was also unsuccessful.Finally, the physician was able to secure the distal tip of the delivery catheter and pull it out via the right groin access, while it was simultaneously advancing from the right intrajugular access site.The delivery system appeared intact, and sensor was remained tethered but potentially looser at the distal end.There were no adverse consequences to the patient.The patient was admitted for observation overnight and discharged the following day."this report reflects information received by fda in the form of a notification per 803.22 (b)(2)".

• Brand Name: GOOSE NECK SNARE KIT/CATHETER
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): MEDTRONIC VASCULAR
• MDR Report Key: 18715202
• MDR Text Key: 335573499
• Report Number: MW5151732
• 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: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/14/2024

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2024
• Patient Sequence Number: 1