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

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record of the product code/lot# combination was conducted with no findings.
Event or Problem Description
The user facility reported that after prep of the glidesheath device, part of the tip detached.The event occurred pre-treatment and there was no patient contact.There were no other devices or equipment used with the reported product.Additional information was received on 11feb2020.The procedure being performed was a heart catheterization.The patient was in stable condition.A new sheath was opened to complete the procedure.The procedure was completed successfully.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.One used 5fr glidesheath a-kit sheath was received for product evaluation.The sheath was returned mated with the dilator.No other accessory components were returned.Visual inspection revealed that the dilator was damaged at the distal tip of the dilator.The dilator was observed under microscope and the tip was confirmed to be torn.The crosscut valve was dissected and observed under microscope; no damage was seen at the center of the valve.Measurements of the sheath shaft were taken from the hub and was found to be 30.9 cm which is within manufacturer specification.No damage was seen at the sheath inner lumen.No other parts of the sheath were found to be detached.No other anomalies were noted with the returned components.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It is likely that once the sheath and dilator was mated, the sheath may have come in contact with a hard surface causing the tip to be torn.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: GLIDESHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton, md
• MDR Report Key: 9793661
• Report Number: 1118880-2020-00059
• Device Sequence Number: 2288782
• Product Code: DYB
• UDI-Device Identifier: 00389701011257
• UDI-Public: 00389701011257
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2020

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 Expiration Date: 12/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 30-2550
• Device Lot Number: XH12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 03/05/2020
• Supplement Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1