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

Model Number	N/A
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2020
Type of Reportable Event	Serious Injury
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
A destination sample was received on june 26, 2020.On july 15, 2020 the user facility reported that the destination dilator split during advancement.The procedure was filter retrieval.The patient was in stable condition.They switched to a cook device to complete the procedure successfully.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide additional information to section b5, to update section h3, and to provide the completed investigation results.One used 8 fr 45 cm destination sheath was received for product evaluation.The dilator was received mated with the sheath.No other accessory components were returned.There was a cut at the dilator tip which was about 0.5cm.There was no damage to the sheath tip.There were no other visual anomalies noted.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
Additional information was received on 26august2020: the dilator was pulled upon vessel entry.It never touched the filter.It was internal jugular access.Additional information was received on 16september2020: the split in the dilator was seen during insertion.There was no sharp object present at the time of insertion.

• Brand Name: DESTINATION RENAL GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton, md
• MDR Report Key: 10373868
• Report Number: 1118880-2020-00193
• Device Sequence Number: 3120428
• Product Code: DYB
• UDI-Device Identifier: 00389701009414
• UDI-Public: 00389701009414
• Combination Product (Y/N): N
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2020

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: 01/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 54-84501
• Device Lot Number: XK28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2020
• Initial Date Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 09/17/2020
• 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
• Patient Age: 72 YR
• Patient Weight: 98