MAUDE Adverse Event Report: TERUMO MEDICAL CORP. GLIDESHEATH ACCESS KIT; HYDROPHILIC COATED INTRODUCER SHEATH

Model Number 30-1060

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Inadequate Pain Relief (2388); Foreign Body In Patient (2687)

Event Date 12/23/2016

Event Type  malfunction  

Event Description

The design of the sheath/ guidewire allows for the complete insertion of the wire through the one way valve.On (b)(6) 2017: right humerus imaging: "apparent retained guide projects over the proximal right arm and right lung apex." on (b)(6) 2016: diagnostic cardiac cath.On (b)(6) 2017: patient reported unbearable pain right arm.On (b)(6) 2017: femoral and peripheral angiography, foreign body removal.

• Brand Name: GLIDESHEATH ACCESS KIT
• Type of Device: HYDROPHILIC COATED INTRODUCER SHEATH
• Manufacturer (Section D): TERUMO MEDICAL CORP.; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 6903577
• MDR Text Key: 87860779
• Report Number: MW5072525
• Device Sequence Number: 1
• Product Code: DYB
• 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: 09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 30-1060
• Device Catalogue Number: 30-1060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Weight: 66