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

Catalog Number 538-476

Device Problem Material Twisted/Bent (2981)

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

Event Date 10/05/2020

Event Type  Injury  

Event Description

Patient in cath lab for a scheduled right and left heart catheterization.Access per right radial artery and a 6 fr sheath placed noted extreme tortuosity in the brachiocephalic region on the right.A tiger catheter was advanced over a 0.035 j wire and angiography of the left coronary artery was performed.This catheter would not torque to cannulate the right coronary artery so exchanged over the wire for a jr4 catheter.Again this would not torque and we noted kinking on the catheter.Removed this catheter over the wire and advanced a 4-fr 3drc catheter.This catheter also would not torque despite placing a wire within.Hemodynamic damping was noted with a kink in the catheter, which would not straighten easily with jwire or 0.035 wire.Did not try to force this out of the sheath and instead administered lidocaine to the right groin and tried grion approach to straighten the catheter to facilitate its extraction.Then advanced en snare device and with this, we were able to capture the tip of the 3drc catheter and this was pulled down to the level of abdominal aorta and the tip of the 3drc catheter was severed by the snare and removed.Pulled back radial sheath and catheter as a unit with virtually no resistance.All catheters, wires and sheath removed.Fda safety report id# (b)(4).

• Brand Name: CORDIS ANGIOGRAPHIC CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; miami lakes FL 33014
• MDR Report Key: 10657820
• MDR Text Key: 211031422
• Report Number: MW5097166
• Device Sequence Number: 1
• Product Code: DQO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 538-476
• Device Lot Number: 17847301
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 65 YR