MAUDE Adverse Event Report: COVIDIEN RELIACATCH; LAPAROSCOPE, GENERAL PLASTIC SURGERY

Model Number CATCH12

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Death (1802); Exsanguination (1841); Vascular Dissection (3160)

Event Date 03/13/2020

Event Type  Death  

Event Description

Scheduled for a robotic assisted left upper lobectomy for bronchogenic adenocarcinoma that had not spread to other organs.The procedure was performed with the assistance of the intuitive surgical xi robot.A total of 4 robotic port sites were created along the left lateral chest wall between the 7th and 8th ribs.An access and specimen retrieval site was created 2 interspaces below the 7th and 8th ribs.Surgeon had completed the dissection of the left upper lobe and had deployed the medtronic reliacatch 12 mm retrieval bag.Specimen was being loaded into the bag when surgeon noted a large amount of blood in cavity.Anesthesia noted no bp (blood pressure).Surgeon converted to open thoracotomy, massive transfusion protocol implemented along with cpr acls (advanced cardiac life support) protocol.Patient never responded to any of the resuscitative efforts and expired.Afterwards it was noted that the left pulmonary artery had a tear in it.The retrieval bag was inspected and it was noted that there was a piece of the ring wire protruding out.Medtronic reliacatch 12 mm retrieval bag should be deployed safely so that there is no injury caused to any adjacent organs.In this event, it was thought that the protruding wire caused the pulmonary artery tear.There was a medtronic representative in the operating room during the event.

• Brand Name: RELIACATCH
• Type of Device: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN; 60 middletown ave; north haven CT 06473
• MDR Report Key: 9930749
• MDR Text Key: 186619324
• Report Number: 9930749
• Device Sequence Number: 1
• Product Code: GCJ
• 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: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CATCH12
• Device Catalogue Number: CATCH12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/23/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 28105 DA
• Patient Weight: 85