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

Model Number	N/A
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/19/2019
Type of Reportable Event	Malfunction
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
The user facility reported that the destination sheath was used in the left groin for access during a vascular intervention of the right superficial femoral artery (sfa).The first sheath used was a 6fr precision sheath in the left common femoral artery.The sheath was then exchanged for the destination sheath over a glidewire advantage.The physician met resistance at the insertion site.The sheath became flared from the dilator and would not track over the wire into the artery.The sheath was then exchanged for another destination which advanced easily into the vessel.There was no blood loss or patient injury due to this event.The patient has previously had multiple procedures in this same access site.The patient was stable and the procedure outcome was successful.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.One 6fr 45cm destination sheath and dilator were returned for product evaluation.Visual inspection revealed that damage was seen at the tip of the sheath.The sheath tip was observed under microscope and the tip of the sheath was wrinkled and partially flattened.The dilator shaft did not have any damage or gross anomalies.The dilator tip was viewed under microscope and no damage was observed.Dimensional testing was performed.The sheath od measured at 0.1094 inches which is within the manufacturer's specifications.The dilator od measured at 0.0830 inches which is within the manufacturer's specifications.The hydrophilic coating was verified by running water over the sheath.There was a profound difference in contact angle of the water between coated and uncoated portions.Water was attracted to the coated portion of the sheath and spread across the shaft.The sheath had a slippery feel which confirmed the presence of the hydrophilic coating on the sheath.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 the damage on the sheath tip can be attributed to difficulties at the point of insertion due to scar tissue.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: RENAL GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 9482334
• Report Number: 1118880-2019-00357
• Device Sequence Number: 296755
• Product Code: DYB
• UDI-Device Identifier: 00389701008837
• UDI-Public: 00389701008837
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K012854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2019

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: 01/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 54-64501
• Device Lot Number: XK28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 01/20/2020
• 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 ADVANTAGE
• Patient Age: 83 YR