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

Model Number	N/A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Date of Event	08/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.For this reason, (b)(4) has been referenced in the conclusions section.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 when the doctor inserted the 5/6 glidesheath slender it bent in two places with hardly any force.The doctor was performing a percutaneous coronary intervention (pci) and achieved radial access easily.The sheath was exchanged for another sheath with the same lot number without any issues.The procedure outcome was successful after the exchange of the sheath.The patient was in stable condition, and blood loss was less than 250cc.There was no other equipment or devices being used with the reported product.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation.One 6fr glidesheath slender was received for product evaluation.No other components were received with the sheath.The sheath was subjected to visual analysis.There were two notable kinks present at 1.046" and 3.193" from the distal tip of the sheath.Additionally, distal to the hub of the sheath there was damage indicative of torsional force.There was deformation that followed a spiral pattern approximately 3.697" from the distal end of the sheath.There is no evidence that this event was related to a device defect or malfunction.Based on the investigation, off-axis forces have been known to cause kinks.It is likely that applying a twisting motion to the sheath hub led to the damage distal to the hub.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: GLIDESHEATH SLENDER NITINOL
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 7846815
• Report Number: 1118880-2018-00109
• Device Sequence Number: 13732326
• Product Code: DYB
• UDI-Device Identifier: 00389701011981
• UDI-Public: 00389701011981
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K142183
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2018

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: 11/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 60-1065
• Device Lot Number: WG20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Initial Date Received by Manufacturer: 08/22/2018
• Supplement Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 09/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 81