MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION GLIDESHEATH SLENDER NITINOL; INTRODUCER, CATHETER

Model Number N/A

Device Problem Material Separation (1562)

Patient Problems Thrombosis (2100); Device Embedded In Tissue or Plaque (3165)

Event Date 04/26/2019

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record of the product code/lot# combination was conducted with no findings.

Event Description

The user facility reported that the doctor felt resistance when advancing the glidesheath nitinol wire thru the access needle.While attempting to remove the wire, it frayed and broke off.A portion of the wire remained in the patients right radial artery.New access was gained, and the procedure was completed successfully.The procedure was a left heart diagnostic, normal.A surgical consult is pending.The patient was reported to be stable and in no pain.There was no other devices or equipment used with the reported product.

Manufacturer Narrative

The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.

Event Description

Additional information was received on may 10, 2019.The doctor at (b)(6) was performing a diagnostic left heart catheterization.The doctor advanced the access wire through the access needle multiple times resulting in the wire tip to prolapse on itself and form a knot.As the doctor felt resistance, he removed the wire and needle.A tr band was placed on the procedure site and hemostasis was successfully achieved.The doctor then moved up the arm closer to the elbow to gain his second access.Access was successful with a glidesheath slender sheath.The diagnostic procedure was completed, and a tr band was placed on the patient to achieve hemostasis.The staff asked the doctor if the patient's wrist was going to be evaluated.The wrist was x-rayed in recovery and it was discovered that a portion of the wire remained in the patient.The patient was sent to vascular surgery for consult.The vascular surgeon from mercy was consulted.An angiogram was performed.It was determined that the wire was embedded in the soft tissue, not in the artery.The vascular surgeon determined to leave the wire in the patient because the wire being left in the patient was not harmful to the patient.He then treated the thrombosis in the patient's artery.He stated it was not due to the wire but a result from the second access site.

Manufacturer Narrative

This report is being submitted as follow up no.2 to update , and to provide the completed investigation results.One used 5 fr glidesheath slender guidewire and needle were returned for evaluation.Visual inspection revealed that the guidewire was returned in an unraveled state, which was visually examined under the microscope.The distal tip of the guidewire had uncoiled to the point where the coil is fused with the core of the guide wire.Dimensional testing was performed.The stiff end measured to be 0.0205" using the vernier caliper, which is within the manufacturer specification limit of 0.0205" to 0.0210".The floppy end of the guidewire was stuck inside the needle.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.Based on the investigation results it is likely that the guidewire shearing may have occurred if the guidewire was withdrawn through the needle.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: GLIDESHEATH SLENDER NITINOL
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 8601077
• MDR Text Key: 144741387
• Report Number: 1118880-2019-00090
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00389701011363
• UDI-Public: 00389701011363
• Combination Product (y/n): N
• PMA/PMN Number: K142183
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 50-1050
• Device Lot Number: XA09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Initial Date Manufacturer Received: 04/26/2019
• Initial Date FDA Received: 05/10/2019
• Supplement Dates Manufacturer Received: 05/10/2019; 06/03/2019
• Supplement Dates FDA Received: 05/29/2019; 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR