MAUDE Adverse Event Report: TERUMO CORP TERUMO GLIDESHEATH; CATHETER INTRODUCER

Catalog Number RF6F10PA

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2015

Event Type  malfunction  

Event Description

Terumo glidesheath doesn't have an opening on the end, it's closed.Physician was unable to pass the wire through the opening delaying care on stemi (st-elevation myocardial infarction) patient.Another glidesheath obtained and procedure continued.No patient harm.

• Brand Name: TERUMO GLIDESHEATH
• Type of Device: CATHETER INTRODUCER
• Manufacturer (Section D): TERUMO CORP; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 4877553
• MDR Text Key: 5866296
• Report Number: 4877553
• Device Sequence Number: 1
• Product Code: DYB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: RF6F10PA
• Device Lot Number: 141210
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/24/2015
• Event Location: Hospital
• Date Report to Manufacturer: 06/30/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Age: 47 YR
• Patient Weight: 99