MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION GLIDESHEATH SLENDER; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Weight: (b)(6).Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device was 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 there was deconstruction of sheath upon removal of lutonix balloon from dorsalis pedis (dp) access.The doctor had dp access of the foot with a 5fr glidesheath slender sheath.The physician was intervening the superficial femoral artery (sfa) using balloons, and csi devices from his access in the foot.All devices used were 5fr devices, and upon removal of a 5x150 lutonix balloon, the entire inner sheath came out of patient.Leaving just the hub of the sheath secured with a tegaderm to the patient.The doctor had wire access and placed a 2nd slender sheath without issue and completed the case.No reported consequence to the patient.The patient was in stable condition.There was no patient injury/medical or surgical intervention required.The procedure outcome was a success.Additional information was received on 30sept2020.The csi device was a diamond back 360 1.5 solid crown.Lutonix balloon 5 x 150 that was used was a.035".The interventions that were performed on the superficial femoral artery (sfa) lesion were 1 atherectomy, 2 drug coated balloons (dcb), and 1 percutaneous transluminal angioplasty (pta).A hemostatic adaptor was not attached to the lutonix catheter shaft.However, it had a stopcock that was attached to the endoflator.The balloon was allowed to deflate completely before attempting to pull the balloon back through the sheath, they watched it under fluoro to ensure deflation before removing.It is unknown if the lutonix balloon catheter shaft kinked or bent prior to removing.The balloon was allowed to deflate before removing for approximately 5-10 seconds as it was watched under fluoro to ensure deflation before removing.The sheath shaft separated completely from the hub, and got pulled back through the valve, when removing the lutonix balloon.The other drug coated balloon (dcb) was snug as well.The dorsalis pedis (dp) artery was not heavily calcified or diseased.There was no damage noted on the sheath prior to insertion and there were no difficulties inserting the sheath.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.One 5fr 10cm glidesheath slender with a 5x150mm lutonix balloon was returned for product evaluation.No other components were received for product evaluation.Visual inspection revealed that the sheath was folded in reverse and exited through the valve in the opposite direction.The inner diameter of the tip of the sheath was measured to be 1.80 mm which was within the manufacturer specification.Based on the returned device, the complaint can be confirmed for the sheath/catheter mechanical separation.The device was in a conforming state when released from terumo control.There is no indication that any manufacturing, design or quality system issues may have led to this event.Currently, no action is recommended since this risk evaluation is within the predetermined limits in the fmea.

• Brand Name: GLIDESHEATH SLENDER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 10719295
• Report Number: 1118880-2020-00254
• Device Sequence Number: 3457521
• Product Code: DYB
• UDI-Device Identifier: 00389701012049
• UDI-Public: 00389701012049
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K173831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2020

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: 10/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 80-1050
• Device Lot Number: YF20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Initial Date Received by Manufacturer: 09/25/2020
• Supplement Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 12/22/2020
• 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: DIAMONDBACK360 1.5 SOLID CROWN; INTERVENTIONAL BALLOONS; LUTONIX BALLOON 5 X 150
• Patient Age: 76 YR
• Patient Weight: 113