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

Model Number N/A

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/07/2022

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: supervisor 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 number combination was conducted with no findings.

Event Description

The user facility reported that the involved r2p destination slender device sheath had a bad edge.There was no patient injury, and medical or surgical intervention was not required.Additional information was received on 27 jun 2022: at the time the bad edge was discovered the procedure performed on the patient was a heart catheterization.It was reported that they "believe the sheath condition was discovered during the procedure." the patient was in stable condition.There was no other equipment or devices used with the involved device.

Manufacturer Narrative

This report is being submitted as follow up no.1 to add additional information to sections a1, a2, a3, update section h3, and to provide the completed investigation results.One r2p destination slender was returned for product evaluation.The returned device included the sheath and dilator.The product was subjected to visual analysis.The sheath and dilator were fully mated.The sheath tip was found to be deformed.Dried blood-like substances were found on the dilator near the sheath-dilator transition.The complaint can be confirmed for sheath tip mechanical damage.The exact root cause cannot be determined.The likely root cause is the atraumatic tip came into contact with an obstruction during insertion.The device history record (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 failure mode and effects analysis (fmea).

• Brand Name: R2P¿ DESTINATION SLENDER¿ GUIDING SHEATH
• Type of Device: 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: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 15067388
• MDR Text Key: 304631233
• Report Number: 1118880-2022-00058
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00389701012360
• UDI-Public: 00389701012360
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/20/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2024
• Device Model Number: N/A
• Device Catalogue Number: GS-R6ST1C75W
• Device Lot Number: 0000104778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2022
• Initial Date Manufacturer Received: 06/24/2022
• Initial Date FDA Received: 07/20/2022
• Supplement Dates Manufacturer Received: 08/15/2022
• Supplement Dates FDA Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male