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

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	08/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight: between 90-100 kg.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 the destination sheath could not be introduced into an iliofemoral bypass.It got stuck on the anterior bypass-wall and got crushed.The user was not pleased by the transition of the dilator to the sheath.The dilator should be longer to have more guiding of the device on the wire.The procedure was finalized with a sheath by biotronik as intended.There was no significant delay.There was no harm to the patient.Additional information was received on 11aug2020: it was reported that it was not possible to insert the sheath.The issue was not procedure related.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to update section h3, and to provide the completed investigation results.One used 7fr 45 cm destination sheath and dilator were received for product evaluation.The components were mated when received.Visual inspection revealed damage at the distal tip of the sheath; damage was also seen on the dilator.Microscopy confirmed that the sheath tip was damaged in a fashion where there were folds on the distal edge of the sheath along with some jagged edges.The outer diameter of the sheath was also found to be in specification.The outer diameter of the dilator was measured to be in specification.The length of the dilator was also found to be within specifications.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.Based on the investigation results it is likely that that the sheath met extraneous material in situ which could have caused the reported event.However, the exact cause of the reported event cannot be definitively determined based on the available information.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section d9, and to update section h3.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.

• 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: 10476976
• Report Number: 1118880-2020-00206
• Device Sequence Number: 19442693
• Product Code: DYB
• UDI-Device Identifier: 00389701006192
• UDI-Public: 00389701006192
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2020

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: 03/21/2022
• Device Model Number: N/A
• Device Catalogue Number: RSR04
• Device Lot Number: XM23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Initial Date Received by Manufacturer: 08/07/2020
• Supplement Date Received by Manufacturer: 09/03/2020; 10/19/2020
• Initial Report FDA Received Date: 09/01/2020
• Supplement Report FDA Received Date: 09/28/2020; 10/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR