MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION DESTINATION PERIPHERAL GUIDING SHEATH; 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	04/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.One 65 cm 6fr destination sheath and dilator were received for product evaluation.The sheath and dilator were not received mated together but instead were fully separate from one another and they were both folded into a u-shape.Visual inspection revealed there was no damage on the dilator.Visual inspection of the sheath revealed that the distal end of the sheath was flattened just above the soft tip and the gold marker.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.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 based upon the evaluation of the actual device.The user facility reported an unknown issue with the destination dilator tip.The procedure was successful.There was no patient injury, medical/surgical intervention required.The patient's condition was stable.Additional information was received on 05may2020.The reported issue was noticed during prep with the patient present.They opened another rsp01 and finished the procedure successfully.The procedure was a peripheral diagnostic cath.Additional information was received 10jun2020.It was the tip of the sheath, not the dilator.

• Brand Name: DESTINATION PERIPHERAL GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton, md
• MDR Report Key: 10148637
• Report Number: 1118880-2020-00143
• Device Sequence Number: 14013349
• Product Code: DYB
• UDI-Device Identifier: 00389701007786
• UDI-Public: 00389701007786
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172995
• 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): 06/12/2020

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: 04/30/2022
• Device Model Number: N/A
• Device Catalogue Number: RSP01
• Device Lot Number: XN06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 06/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1