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

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has not 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 during pullback of a boston charger.035 6x120 pta balloon, the balloon brought the glidesheath back with it causing it to prolapse.The patient was reported to be fine.The procedure outcome was successful.Additional information was received on 9/10/2018.The procedure being performed was a peripheral procedure (leg case) being performed via pedal access.The patient was reported to be in stable condition.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date.The actual device was returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to update and provide the completed investigation results.One 5fr glidesheath slender was returned for evaluation.No other components were received with the sheath.Visual inspection revealed that the sheath was folded in reverse and exited through the valve in the opposite direction.There is no evidence that this event was related to a device defect or malfunction.Based on the investigation results it is likely that the boston scientific charger 6mm x 120mm balloon dilation catheter that was used with the sheath could have repeated inflation and deflations of the balloon coupled with off axis movement created a constriction which led to negative pressure around the inner lumen which in turn led to inability of parts of the balloon surface to slide freely without the sheath.Very strong withdrawal forces in such instance led to complete reversal and folding of the sheath through the valve as it followed the withdrawal trajectory of its mated device.However, the exact caused of the reported event cannot be definitively determined.

• 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: 7872343
• Report Number: 1118880-2018-00121
• Device Sequence Number: 13498782
• Product Code: DYB
• UDI-Device Identifier: 00389701011363
• UDI-Public: 00389701011363
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 09/13/2018

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: 08/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 50-1050
• Device Lot Number: VN24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 09/17/2018; 10/22/2018
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 09/18/2018; 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1