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

Model Number 80-1050

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 10/15/2020

Event Type  Injury  

Event Description

When removing a lutonix 7x40 drug-coated balloon (dcb) out of the sheath, the sheath separated from the sheath hub.Doctor had to perform a cutdown of the tibial to get the piece.

• Brand Name: GLIDESHEATH SLENDER
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd; elkton MD 21921
• MDR Report Key: 10754656
• MDR Text Key: 213663176
• Report Number: 10754656
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 80-1050
• Device Catalogue Number: 80-1050
• Device Lot Number: XN13
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/22/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/29/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 76