MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION DESTINATION RENAL GUIDING SHEATH; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Initial reporter: occupation - rn supervisor.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.This report is for the second device reported, for the first device reported prior to use of the same patient see mdr 1118880-2020-00221.
Event or Problem Description
The user facility reported that the destination device sheaths were kinked inside the package and were unusable for the procedure.There was no patient injury, medical/surgical intervention required.Additional information was received on 25aug2020.They were both found kinked within the package; however, one was opened for inspection.They used an undisclosed competitors' sheath to complete the procedure.The patient was in stable condition.
Additional Manufacturer Narrative
One unused 6fr 90 cm destination sheath and dilator was received for product evaluation.The dilator was placed in the packaging card, unmated when received.Visual inspection of the sheath revealed a flattened segment.Measurements of the first flattened segment was found to be starting at 70.5 cm and ending at 73.5 cm from the hub.No other visual anomalies were observed.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 the flattening of the sheaths occurred due to the application of transverse compressive forces.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: DESTINATION RENAL GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 10539914
• Report Number: 1118880-2020-00222
• Device Sequence Number: 3161845
• Product Code: DYB
• UDI-Device Identifier: 00389701007847
• UDI-Public: 00389701007847
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K172995
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: N/A
• Device Catalogue Number: RSC05
• Device Lot Number: WN28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention