MAUDE Adverse Event Report: TERUMO GLIDESHEATH SLENDER NITINOL KIT 5FR; INTRODUCER, SHEATH NITINOL

Model Number	50-1050
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The product was a glide sheath slender size french and apparently as doctor had already inserted the sheath into the patient's left wrist, and i guess as it was coming out the piece came apart, it actually broke apart so we had to pull it from the sterile field and we were not able to reuse it, which we typically should have been able to.

• Brand Name: GLIDESHEATH SLENDER NITINOL KIT 5FR
• Common Device Name: INTRODUCER, SHEATH NITINOL
• Manufacturer (Section D): TERUMO; 265 davidson ave; suite 320; somerset NJ 08873
• MDR Report Key: 11071882
• Report Number: 11071882
• Device Sequence Number: 11652905
• Product Code: DYB
• UDI-Device Identifier: 00389701011363
• UDI-Public: (01)00389701011363(17)220831(10)YD18
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2020
• Report Date (Section F): 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 50-1050
• Device Catalogue Number: 50-1050
• Device Lot Number: YD18
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/24/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 57
• Date Report Sent to FDA: 12/11/2020