MAUDE Adverse Event Report: MARINER HYDROPHILIC ANGIOGRAPHIC CATHETER

Catalog Number UNKNOWN

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/19/2020

Event Type  Injury  

Manufacturer Narrative

The reported device has yet to be returned to the manufacturer for a device evaluation.An investigation into the root cause for product problem is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Event Description

A risk manager reported an issue with a mariner cobra (2) angiographic catheter.A (b)(6) year old female patient had a transjugular liver biopsy on friday, (b)(6) 2020 in interventional radiology (ir).The patient tolerated the procedure well, reported no symptoms related to this procedure or other issues, and was discharged home.She was completing an additional workup for possible liver biopsy when the scan on (b)(6) 2020 identified a "linear hyperdensity within the cardiac right atrium and right ventricle, suspicious for a catheter fragment".The patient was informed of the retained object, and discussion of the next steps ensued.She returned to the ir unit for retrieval of the catheter fragment on (b)(6) 2020.The plastic cheater sheath covering the catheter was removed from the right atrium without complication.The patient was discharged home in her usual state of health the same day.The reporting medical facility performed their own internal investigation.It was determined to make angiodynamics aware that their main complaints were the straightening sheath was too close to the same color as the catheter, and the design of the peel away tab was poor in that it was nearly flush with the catheter.It was indicated the reported device is available for return to the manufacturer for a device evaluation.

Manufacturer Narrative

As the reported device was not returned, angiodynamics is unable to perform a device evaluation.However, a picture of the "plastic component removed from the patient" was provided.A review of this picture confirmed that the plastic component in question is the straightener placed over the catheter tubing and not a fractured piece of the angiographic catheter itself.The customer's reported complaint description cannot be confirmed given the patient adverse event nature of this issue.A review of the complaint event description has determined that the likely root cause of the straightener component being placed into and retained in the patient's vasculature is related to end user error during advancement of the angiographic catheter into the patient (i.E.Also inserting tip straightener into the patient at same time as catheter tip).The dfu states the following regarding use and removal of tip straighteners: angiodynamics furnishes several of its catheters with a tip straightener.To straighten the catheter tip, hold the distal end of the tip straightener between the thumb and forefinger and pull the straightener up the catheter shaft until the tip is straight.Then place the catheter tip over the positioned guidewire and introduce the catheter in the normal manner.To remove the tip straightener from the catheter, gently slide the straightener down the catheter shaft to the strain relief.Continue to gently pull until the straightener opens and slides off the catheter.A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).

• Brand Name: MARINER HYDROPHILIC ANGIOGRAPHIC CATHETER
• Type of Device: MARINER HYDROPHILIC ANGIOGRAPHIC CATHETER
• MDR Report Key: 11259034
• MDR Text Key: 229637258
• Report Number: 1319211-2021-00008
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K151724
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR