MAUDE Adverse Event Report: MEDTRONIC, INC AMPLATZ GOOSENECK SNARE KIT 20MM; CATHETER, EMBOLECTOMY CLOSE

Model Number GN2000

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/04/2023

Event Type  malfunction  

Event Description

In the process of using a snare, the tip broke off in the patient.Another snare was used and successfully retrieved the tip with no harm to the patient.The snare and tip have been retained.Manufacturer response for snare, amplatz gooseneck snare kit 20mm (per site reporter), mfg notified by site.

• Brand Name: AMPLATZ GOOSENECK SNARE KIT 20MM
• Type of Device: CATHETER, EMBOLECTOMY CLOSE
• Manufacturer (Section D): MEDTRONIC, INC; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 18265991
• MDR Text Key: 329722301
• Report Number: 18265991
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/05/2023

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 Model Number: GN2000
• Device Lot Number: B583694
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/05/2023
• Event Location: Hospital
• Date Report to Manufacturer: 12/05/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/05/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1