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

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	05/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier - requested, not provided.Age & date of birth - requested, not provided.Patient sex - requested, not provided.Weight - requested, not provided.Ethnicity - requested, not provided.Race - requested, not provided.Implanted date: device was not implanted.Explanted date: device was not explanted.One 6fr glidesheath slender device along with the dilator was received for product evaluation.Visual inspection revealed that the sheath had damage at the tip and two kinks were observed, one near the hub and the other in the middle of the sheath.The dilator was examined, and a bend was observed in the middle of the dilator.A review of the device history record of the product code/lot# combination was conducted with no findings.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 difficulties during insertion of the sheath into the patient may have caused the reported issue.However, the exact cause of the reported event cannot be definitively determined based on the available information.
Event or Problem Description
This report has been deemed reportable upon investigation of the actual device.The user facility reported that the glidesheath slender was used during the angiogram procedure, and the sheath malfunctioned.The patient's condition was stable, and the angiogram was successful.The blood loss was less than 250cc's.There was no patient injury, medical/surgical intervention required.Additional information was received on 28jun2019.They utilized the guidewire; the sheath was being placed over the wire and it kinked and was unable to be utilized for access.The puncture site was left dorsalis pedis artery, retrograde.Lesion treatment history was reported to be left anterior tribal occluded, left posterior trial occluded, left peroneal artery patent.

• Brand Name: GLIDESHEATH SLENDER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton, md
• MDR Report Key: 10153673
• Report Number: 1118880-2020-00152
• Device Sequence Number: 11307120
• Product Code: DYB
• UDI-Device Identifier: 00389701011332
• UDI-Public: 00389701011332
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/15/2020

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: 06/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 50-1060
• Device Lot Number: XA02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 06/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1