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	08/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: requested, not provided.Weight: (b)(6) kg.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reported that during a left leg venogram with access from the left tibial vein, a 6x100 bsc mustang balloon was being withdrawn deflated when the sheath inverted itself and came out through the sheath hub.Pressure was held for hemostasis.Additional information was received on 13aug2021.There were no issues with insertion of the glidesheath (gs) or tortuous anatomy.The patient was in stable condition.The estimated blood loss was less than 250cc.
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 6fr glidesheath slender was returned for product evaluation.The returned sample included the sheath.The sheath was subjected to visual analysis.The sheath had fully prolapsed and inverted back through the sheath hub in the opposite direction of its intended orientation.The sheath hub was observed under x-ray.The caulking pin was observed to be intact.The complaint can be confirmed, for sheath mechanical damage.The exact root cause cannot be determined.The likely root cause is the balloon was not fully deflated.The dhr review determined, that 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 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: 12419151
• Report Number: 1118880-2021-00200
• Device Sequence Number: 17059249
• Product Code: DYB
• UDI-Device Identifier: 00389701011332
• UDI-Public: 00389701011332
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2021

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: 09/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 50-1060
• Device Lot Number: YE15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Initial Date Received by Manufacturer: 08/06/2021
• Supplement Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 10/26/2021
• 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: MUSTANG BALLOON
• Patient Age: 38 YR
• Patient Weight: 84