MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION (TMC) SLENDER GUIDING SHEATH 95CM; INTRODUCER, CATHETER,

Model Number	GS-R6ST1C95W
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier ¿ (b)(6).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.(b)(4).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 device guiding sheath was kinked.Specifically, the distal kink.There were no issues with the procedure outcome.Additional information was received on 11january2021: the procedure performed was for a patient that had a stroke.There were no difficulties with arterial access.A microvention - sofia and gateway 2.5x9 was used with the involved device.The kink was not an interference to the case.It was recognized once it was removed from the patient.The patient was in stable condition.There was no blood loss greater than 250cc¿s.
Event or Problem Description
This report is being submitted as a follow up report.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.One 95 cm 6fr r2p destination sheath was received for product evaluation.The sheath was subjected to visual analysis and no damage was noted along the sheath.The sheath shaft was viewed under microscope and a slight bend was noted on the sheath at 4.92 in and 30.98 in from the sheath hub.No other anomalies or damage was noted.The sheath od measured at 0.1001 inches which is within specifications.The complaint can be confirmed for sheath mechanical damage due to the slight bend noted on the sheath shaft.Images from the angiogram did not show a kink in the sheath.There was no harm to the patient and the slight bending is inherent from use of the device during the procedure.It is likely the tortuous anatomy of the right carotid artery caused the mechanical damage noted on the sheath.The device was in a conforming state when released from terumo control.There is no indication that any manufacturing issues may have led to this event.Currently no action is recommended since this risk evaluation is within the predetermined limits in the failure mode and effects analysis (fmea).

• Brand Name: SLENDER GUIDING SHEATH 95CM
• Common Device Name: INTRODUCER, CATHETER,
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION (TMC); 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 11205069
• Report Number: 1118880-2021-00004
• Device Sequence Number: 16740423
• Product Code: DYB
• UDI-Device Identifier: 00389701012384
• UDI-Public: 00389701012384
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K193125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2021

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: GS-R6ST1C95W
• Device Catalogue Number: GS-R6ST1C95W
• Device Lot Number: YF13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 01/20/2021
• Supplement Report FDA Received Date: 03/17/2021
• 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: MICROVENTION - SOFIA AND GATEWAY 2.5X9
• Patient Age: 54 YR