MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION R2P¿ DESTINATION SLENDER¿ GUIDING SHEATH; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2019
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 when they were inserting the sheath into the patient's artery the dilator would not stay locked in place in the sheath.The patient was stable, and the procedure was completed successfully.Additional information was received on 14oct2019.The procedure performed was a diagnostic runoff.A second terumo sheath was used to successfully complete the procedure.
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 6fr r2p destination sheath and dilator were returned for product evaluation.Visual inspection revealed a kink was observed 0.8 cm from the sheath hub.Microscopy confirmed that the sheath was damaged and kinked.The sheath also had a 4 cm flattened portion 140 cm from the hub.There was no damage seen on the dilator.Functional testing was performed.The components were attempted to be mated together but could not be due to the flattened portion on the sheath; the dilator tip stops halfway through the flattened portion of the sheath shaft.The dilator was cut and then mated with the sheath and the components securely mated together and locked and did not come apart.Dimensional testing was performed.Measurements were taken of the sheath diameter and it measured at 0.09984" which was within the manufacturer specification.The sheath inner diameter measured at 0.0875 inches which is within the manufacturer specification.Measurements were taken of the dilator diameter and it measured at 0.08266" which was within the manufacturer specification.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.The exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: R2P¿ DESTINATION SLENDER¿ GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 9292901
• Report Number: 1118880-2019-00313
• Device Sequence Number: 13979230
• Product Code: DYB
• UDI-Device Identifier: 00389701011561
• UDI-Public: 00389701011561
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K171491
• 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,Followup
• Report Date (Section B): 11/07/2019

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: GS-R6ST1C15W
• Device Lot Number: WG27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 12/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1