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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	05/18/2020
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.
Event or Problem Description
The user facility reported that the tip of the destination guiding sheath dislodged during the procedure.The physician was able to snare the broken portion during the procedure.The patient condition was stable, and the procedure outcome was positive.There was no patient injury, medical/surgical intervention required.Additional information was received on 21may2020.The procedure performed was a left lower extremity angiogram.Testing was confirmed that no remaining pieces where left behind.There was no extra blood loss.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide a correction to section d10.It was initially reported that the actual device was received; however, it was confirmed that an empty box was received.Therefore, section d10 has been updated to reflect the date of which the actual sample was received.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.
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 6 fr 90 cm destination sheath was received for evaluation.Visual inspection of the sheath revealed damage was at the tip of the sheath.The soft tip was observed under microscope and was found to be separated from the sheath shaft.Upon examination, it was observed that there was discontinuity in melt bond of soft tip material to the sheath.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.Terumo is further investigating the reported event.

• 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: 10137279
• Report Number: 1118880-2020-00124
• Device Sequence Number: 2163435
• Product Code: DYB
• UDI-Device Identifier: 00389701007847
• UDI-Public: 00389701007847
• 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,Followup,Followup
• Report Date (Section B): 06/10/2020

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: 04/30/2022
• Device Model Number: N/A
• Device Catalogue Number: RSC05
• Device Lot Number: XN06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2020
• Initial Date Received by Manufacturer: 05/18/2020
• Supplement Date Received by Manufacturer: 06/09/2020; 07/16/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 06/30/2020; 07/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GLIDEWIRE; GLIDEWIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR