MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION TERUMO GLIDESHEATH ACCESS KIT; INTRODUCER, CATHETER

Model Number 60-1060

Device Problems Inadequacy of Device Shape and/or Size (1583); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/10/2019

Event Type  Injury  

Event Description

A 6 fr glidesheath slender access kit used during procedure.After arterial access obtained the physician was unable to advance the sheath onto the guidewire.Upon inspection of the sheath, the hole at the end of the dilator was too small to fit on over the wire.New glidesheath slender kit opened and new sheath and dilator were advanced with no further obstruction noted.Heart cath completed and pt tolerated well.

• Brand Name: TERUMO GLIDESHEATH ACCESS KIT
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 8666219
• MDR Text Key: 147045061
• Report Number: MW5087094
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00389701011974
• UDI-Public: (01)00389701011974
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: 60-1060
• Device Catalogue Number: 60-1060
• Device Lot Number: WP12
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: 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): Required Intervention
• Patient Age: 48 YR
• Patient Weight: 109