MAUDE Adverse Event Report: ANGIODYNAMICS, INC ANGIODYNAMICS STANDARD MICRO INTRODUCER KIT

Lot Number 5289467

Device Problems Disconnection (1171); Component Missing (2306); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2019

Event Type  malfunction  

Event Description

Patient undergoing cerebral angiogram the site was injected with lidocaine 1% overlying the right common femoral artery the groin and arterial access was gained using a micropuncture technique, with the access wire in place the md went to remove the micropuncture sheath the hub disconnected from the main body of the sheath when the medical doctor pulled on the main body of the sheath, approximately one half of it came off.Approx.2 1/2 cm of the tip was missing and still on the wire, attempts to dissect with a hemostat down the wire to identify and remove; unsuccessful attempt.The left common femoral artery was accessed with ultrasound guidance, a 6 french 11 cm sheath was place and flushed, through this a snare was used to capture the distal end of the access wire and withdraw out the left femoral artery sheath - a 5cm sheath was placed over the wire into the right common femoral artery; a 70 cm kumpe was passed antegrade down the access wire and the tip of the was pushed out the left side of the groin.There was not harm to the patient all was retrieved.

• Brand Name: ANGIODYNAMICS STANDARD MICRO INTRODUCER KIT
• Type of Device: STANDARD MICRO INTRODUCER KIT
• Manufacturer (Section D): ANGIODYNAMICS, INC; 26 forest st; marlborough MA 01752
• MDR Report Key: 8365740
• MDR Text Key: 136996004
• Report Number: 8365740
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/20/2019

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: No Information
• Device Lot Number: 5289467
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/20/2019
• Date Report to Manufacturer: 02/25/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 18615 DA