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

Model Number	80-1060
Medical Device Problem Codes	Material Separation (1562); Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided due to hospital policy.A2: age & date of birth: requested, not provided due to hospital policy.A3a: sex: requested, not provided due to hospital policy.A3b: gender: requested, not provided due to hospital policy.A4: weight: requested, not provided due to hospital policy.A5: ethnicity: not provided for animal use.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: inventory coordinator.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 shaft of the sheath came apart from the hub as a 6 french guide was being removed.The shaft then started to come through the hub itself.The type of procedure performed was a coronary angiogram via radial access.Additional information was received on 21aug2024: access was first attempted with a 6 french glidesheath.Resistance was felt, therefore, they switched to the 6 french glidesheath slender involved.Roughly two-thirds of the sheath was inserted, and resistance was felt again.A cordis 6 french jr4 was inserted into the glidesheath slender to support insertion of the remaining third of the sheath.The sheath would not advance, and the case moved forward as planned with a third of the sheath outside of the arteriotomy.The case was completed with third of sheath outside the arteriotomy.The sheath became detached from the hub when the jr4 was being removed.The sheath could be seen exiting the hub "as if it had gripped on to the guide catheter".There was no blood loss.The patient was stable.The procedure was completed successfully.The reported event did not result in patient injury and/or require medical or surgical intervention.
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 6 french gss sheath was returned for assessment.The sheath was kinked throughout and completely pulled out from the sheath hub.The complaint can be confirmed for sheath separation at the hub due to the state of the returned sample.The exact root cause could not be determined.The likely root cause is that the force of progressing the concomitant catheter through the sheath caused the sheath to separate from the hub.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).

• 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 ; 4103927218
• MDR Report Key: 20199925
• Report Number: 1118880-2024-00133
• Device Sequence Number: 17862523
• Product Code: DYB
• UDI-Device Identifier: 00389701012063
• UDI-Public: (01)00389701012063(17)260901(10)0000537580
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2024

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: 09/01/2026
• Device Model Number: 80-1060
• Device Catalogue Number: 80-1060
• Device Lot Number: 0000537580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2024
• 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: CORDIS 5 FRENCH JR4.; CORDIS 6FR JR4 GUIDE CATHETER.; JL3.5 DIAGNOSTIC CATHETERS.
• Patient Sex: Unknown