MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION GLIDESHEATH SLENDER SHEATH

Model Number N/A

Device Problems Difficult to Advance (2920); Material Split, Cut or Torn (4008)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/15/2023

Event Type  Injury  

Manufacturer Narrative

D4: lot number: requested, unknown.D4: expiration date: unknown due to unknown lot number.D4: udi: unknown due to unknown lot number.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.H4: device manufacture date: unknown due to unknown lot number.E3: occupation: nurse manager.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record.The actual device was not returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.

Event Description

The user facility reported that after difficult access, the glidesheath slender nitinol wire sheared inside of the radial artery.Surgical intervention was required to remove the wire from the radial artery.The wire was excised, and the procedure was completed.Finished with double wall sheath.The patient was well, and the procedure was completed successfully.Additional information was received on 28jun2023: the procedure being performed was a left heart catheterization.It was believed to have been a scheduled case.The account checked under flouro to make sure the wire was completely removed.

Manufacturer Narrative

This report is being sent as follow-up # 1 to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The complaint cannot be confirmed for guidewire separation because a sample was not returned for assessment.Without a sample, the exact root cause cannot be determined.The complaint mentions that there was difficult access.The likely root cause of the event is that difficult access caused increased tensional forces to be exerted on the guidewire or that the guidewire was backed up over the needle, causing it to shear.There is no indication that any manufacturing, design or quality system issues may have led to this event.Currently no action is recommended since device was within manufacturing and design specifications when it was released from terumo medical corporation control.

• Brand Name: GLIDESHEATH SLENDER SHEATH
• Type of Device: GLIDESHEATH SLENDER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 17330403
• MDR Text Key: 319183803
• Report Number: 1118880-2023-00364
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173831
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/14/2023

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 Model Number: N/A
• Device Catalogue Number: 50-1060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2023
• Initial Date FDA Received: 07/14/2023
• Supplement Dates Manufacturer Received: 07/21/2023
• Supplement Dates FDA Received: 08/18/2023
• 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
• Treatment: GLIDESHEATH SLENDER A-KIT
• Patient Outcome(s): Required Intervention