MAUDE Adverse Event Report: ABBOTT MEDICAL FAST-CATH¿; INTRODUCER, CATHETER

Model Number 406701

Device Problems Break (1069); Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/23/2023

Event Type  Injury  

Event Description

Occurred during a transcatheter aortic valve replacement (tavr) case.When team went to remove the sheath from the right internal jugular (ij), the sheath and tubing separated.A portion of the tubing remained inside the patient (pt) and was unable to retrieve during the same case.Required removal/retrieval by interventional radiology (ir) team with venous access.Lot # and expiration date is unknown, packaging was discarded.

• Brand Name: FAST-CATH¿
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ABBOTT MEDICAL; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 17266228
• MDR Text Key: 318461676
• Report Number: 17266228
• Device Sequence Number: 1
• Product Code: DYB
• 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: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 406701
• Device Catalogue Number: 406701
• 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: 05/25/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/06/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34675 DA
• Patient Sex: Female