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

Model Number	N/A
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the 5 french pedal sheath (50-1050) broke at the hub when attempting to remove the balloon (6x150 ev3) via left pedal access site.The doctor stated the possibly of the balloon re-wrap may have not been great, and he believed it caused some sort of suction on the sheath shaft itself causing sheath breakage.When removing the balloon, the doctor encountered some resistance and when balloon came out so did the shaft of the sheath (attached to balloon).Only the glidewire advantage, sheath hub, and small portion of the sheath remained.All pieces were removed, and pressure was held at the site for hemostasis.The doctor felt all sheath components were removed from the patient's body.The procedure was complete, and the doctor was pending a final angiogram that could not be done since access was lost at this point.The blood loss was less than 250cc's.The procedure was successful.The patient was in stable condition and discharged home.There was no patient injury or surgical intervention required.
Additional Manufacturer Narrative
Patient race & ethnicity: requested, unknown.Implanted/explanted date: device was not implanted/explanted.A review of the device history record of the product code/lot number combination was conducted with no findings.The actual device was not available; therefore, the actual device will not be 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.1 to provide additional information and to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The complaint cannot be confirmed for sheath separation because the sample was not returned for assessment.The exact root cause could not be determined.The complaint mentions that some resistance was felt when trying to remove the balloon from the sheath.It is likely that the balloon was not fully deflated and that pulling forces during withdrawal caused the sheath to break.Review of the device history record (dhr) showed there were no issues noted during manufacture of the product that could have contributed to this complaint condition.Currently no action is recommended since this risk evaluation is within the predetermined limits in the design failure mode and effects analysis (dfmea).
Event or Problem Description
Additional information was received on 22mar2023: the procedure performed was a lower extremity percutaneous transluminal angioplasty (pta)/atherectomy.

• Brand Name: GLIDESHEATH SLENDER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer Contact: gina digioia ; 950 elkton blvd.; elkton, MD 21921 ; 6402040886
• MDR Report Key: 16566905
• Report Number: 1118880-2023-00025
• Device Sequence Number: 17533031
• Product Code: DYB
• UDI-Device Identifier: 00389701011363
• UDI-Public: 00389701011363
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2023

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: 03/01/2025
• Device Model Number: N/A
• Device Catalogue Number: 50-1050
• Device Lot Number: 0000257923
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 03/17/2023
• Supplement Report FDA Received Date: 03/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EV3 (MEDTRONIC) 6MM X 150MM .035 BALLOON; GA3501 GUIDEWIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Hispanic
• Patient Race: White