MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION R2P DESTINATION SLENDER GUIDING SHEATH; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2021
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 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 the physician performed an intervention from the radial to peripheral (r2p) approach.The case was successful.Upon removing the r2p destination sheath out of the body they noticed that the sheath had started to unravel.There were no parts of the device left behind.The doctor fixed the lesion and patient was doing well.The patient was in stable condition.The estimated blood loss was less than 250cc.The procedure outcome was successful.Additional information was received on 20jan2021.The event occurred intra-operative.The procedure was completed with no complication's and the patient was discharged home.
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 119 cm 6fr r2p destination sheath and valve assembly were returned for product evaluation.During decontamination, the sheath was flushed, and fluid came out of the damaged portion of the sheath at the end of the strain relief close to the hub.Visual inspection revealed that damage was noted at the sheath hub.The outer and inner layers of the sheath jacket were stretched and slightly twisted.There was no damage to the strain relief.Flattening was noted on the sheath at 0.59 inches from the hub.Dimensional testing was performed.The sheath outer diameter measured to be 0.1008 inches which was within the manufacturer's specification.There was no damage noted on the valve assembly.Based on the information provided, the exact root cause of the event cannot be determined.However, it is possible that mishandling of the device during removal of the sheath caused the damage noted on the sheath.It is likely that tensile and torsional forces gradually stretched and twisted the inner and outer layers of 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 fmea.

• Brand Name: R2P DESTINATION SLENDER GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 11324392
• Report Number: 1118880-2021-00015
• Device Sequence Number: 3443538
• Product Code: DYB
• UDI-Device Identifier: 00389701011561
• UDI-Public: 00389701011561
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2021

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: 12/31/2021
• Device Model Number: N/A
• Device Catalogue Number: GS-R6ST1C15W
• Device Lot Number: XH24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 02/12/2021
• Supplement Report FDA Received Date: 03/23/2021
• 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: GLIDEWIRE 400CM BABY J
• Patient Age: 84 YR