MAUDE Adverse Event Report: CORDIS CORPORATION SUPER TORQUE; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 532598B

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 06/28/2019

Event Type  malfunction  

Event Description

Patient was undergoing an endovascular abdominal aortic aneurysm repair.A marking pigtail catheter was inserted through the left common femoral artery and advanced up into the suprarenal aorta.The glidewire was exchanged for a lunderquist stiff wire.At this point there were encountered difficulties with the marked pigtail catheter due to dislodgement of the pigtail markers and therefore the pigtail catheter had to be removed.The pigtail catheter was noted to be transected at its halfway point.The entire pigtail catheter and all the markers were retrieved.

• Brand Name: SUPER TORQUE
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 n.w. 60th ave.; miami lakes FL 33014
• MDR Report Key: 8873289
• MDR Text Key: 153674090
• Report Number: 8873289
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032012034
• UDI-Public: (01)10705032012034
• 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: 07/31/2019

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: Health Professional
• Device Model Number: 532598B
• Device Catalogue Number: 532598B
• Device Lot Number: 17759578
• 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: 07/31/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/08/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 30660 DA
• Patient Weight: 87