MAUDE Adverse Event Report: INARI MEDICAL INC INARI CLOTTRIEVER SHEATH; CATHETER, EMBOLECTOMY

Model Number 50-101

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2021

Event Type  malfunction  

Event Description

Clottriever sheath was not working properly after one use.Would not recapture the sheath during a thrombectomy.Clottriever was not used and removed from field.

• Brand Name: INARI CLOTTRIEVER SHEATH
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): INARI MEDICAL INC; 9 parker suite 100; irvine CA 92618
• MDR Report Key: 11945910
• MDR Text Key: 254531375
• Report Number: 11945910
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/02/2021

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 Model Number: 50-101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/02/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/07/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25185 DA