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

Model Number	N/A
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2020
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 involved destination was used during a pta-stenting procedure.The lesion was situated in the afs at the right side.The puncture site was in the left common femoral artery (cfa).At the puncture site there were no calcifications, due to an earlier surgical procedure the puncture site was heavily fibrotic.During insertion of the destination guiding sheath friction was felt.After it was in position the charger pta catheter was advanced without problems.While retrieving the charger catheter friction was felt.When retrieving the destination sheath a lot of resistance was felt, especially in the first stage when the destination was still in position over the bifurcation.When retrieved it could be seen that the guiding sheath was damaged.In fact, it was nearly cut through totally except for the braiding.The operator added that the damage was probably caused by the fibrosis/scar tissue at the puncture site.There was no harm to the patient.Additional information was received on 28aug2020.The patient's condition was stable.The procedure was completed with the destination.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide additional information in section b5, to update section h3, and to provide the completed investigation results.One used 6 fr 45 cm destination sheath was received for product evaluation.The dilator was not received.No other accessory components were returned.Visual inspection revealed that the shaft of the sheath had broken into two pieces.In addition to this, the sheath shaft was stretched, and the inner stainless-steel coil was exposed.Ifu states: "advance or withdraw the sheath slowly.If resistance is met, do not advance or withdraw the sheath until the cause of resistance has been determined." 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 the presence of heavy fibrosis and scar tissue, steep angle between the common iliac arteries, accompanied with pulling the sheath in the presence of resistance may have led to the reported event.However, 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 23oct2020.The aorta or aorto-iliac arteries were heavily calcified.Resistance was most probably an accumulation of resistance caused by the fibrotic changes in the groin and the calcified aorto-iliac arteries.There was slight tortuosity of the left common iliac artery.The angle was steep; between the common iliac arteries was 32 degrees.The charger balloon catheter was not damaged.

• Brand Name: DESTINATION RENAL GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 10540083
• Report Number: 1118880-2020-00229
• Device Sequence Number: 19623490
• Product Code: DYB
• UDI-Device Identifier: 00389701006185
• UDI-Public: 00389701006185
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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
• Report Date (Section B): 09/16/2020

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: 07/31/2022
• Device Model Number: N/A
• Device Catalogue Number: RSR03
• Device Lot Number: YC05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 10/28/2020
• 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: AMPLATZ GUIDE WIRE BOSTON SC.; CHARGER BALLOON CATHETER 6.0X60 135CM BOSTON SC.; AMPLATZ GUIDE WIRE BOSTON SC.; CHARGER BALLOON CATHETER 6.0X60 135CM BOSTON SC.
• Patient Age: 77 YR