MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION DESTINATION CAROTID 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	05/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ethnicity - requested, not provided.Patient reported to be (b)(6).Implanted date: device was not implanted.Explanted date: device was not explanted.(b)(4).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 the physician took the destination device from the shelf to use for the procedure.While starting to open the package he saw that guiding sheath destination was already kinked in the original package.Additional information was received on 03jun2020.The procedure taking place for the patient at the time of the reported event was an endovascular treatment of stroke.They noticed the issue prior to placing it.They used a second rsc01 to resolve the issue.The patient was in stable condition.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update section h3 and h6, and to provide the completed investigation results.The codes were unable to be selected in the initial report due to an application error; therefore, section h6: patient code has been provided.One 6fr destination sheath, dilator, packaging card and packaging pouch were received for product evaluation.Visual inspection revealed that the dilator and the sheath were returned inside the pouch, nested in the packaging card, and it was noted that the pouch was slightly opened.Two folds were seen on the packaging card at 33 cm and 53.1 cm from the proximal end of the tray.There were kinks noted on the sheath and dilator near the folds on the packaging card.The kink noted on the sheath was 44.1 cm from the sheath hub.The kink noted on the dilator was 58 cm from the dilator hub.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 mishandling of the device and the packaging may have contributed to the damage noted on the sheath and dilator.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: DESTINATION CAROTID GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton, md
• MDR Report Key: 10172981
• Report Number: 1118880-2020-00134
• Device Sequence Number: 11571608
• Product Code: DYB
• UDI-Device Identifier: 00389701006796
• UDI-Public: 00389701006796
• Combination Product (Y/N): N
• Initial Reporter Country: LH
• PMA/510(K) Number: K172995
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2020

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: 04/30/2021
• Device Model Number: N/A
• Device Catalogue Number: RSC01
• Device Lot Number: WN21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Initial Date Received by Manufacturer: 05/26/2020
• Supplement Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 07/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1