MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION (TMC) R2P DEST SLENDER 119CM6FR STR; INTRODUCER, CATHETER

Model Number GS-R6ST1C12W

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2021

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has not 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 Description

The user facility reported that the r2p destination sl guiding sheath was inserted from the right radial artery.When the manipulation of the catheter was almost completed in endovascular treatment (evt), blood leakage was observed from a kinked part in the shaft.The guiding sheath was used to complete the procedure and the procedure was completed successfully.There was no health damage to the patient.The estimated blood loss was less than 250ccs.There was no patient injury, medical/surgical intervention required.There were no other devices or equipment used with the reported product.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The complaint can be confirmed for mechanical damage.Based on the information given, the exact root cause of the event cannot be determined.There is no indication that any manufacturing, design or quality system 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).

Manufacturer Narrative

This report is being submitted as follow up no.2 to provide the device return date in section d9, update section h3, and to provide the completed investigation results.One 119 cm 6fr r2p destination sheath and valve assembly were received for product evaluation.The sheath was subjected to visual analysis and a kink was noted 0.5 cm from the sheath hub, below the strain relief.No damage was noted on the valve assembly.The customer sent a video showing the kink in the sheath.The sheath was leaking blood at the kink in the sheath, which was close to the hub at the proximal end of the sheath, same location as noted in the visual analysis.Based on the investigation, the complaint can be confirmed for mechanical damage.The exact cause of the event cannot be determined however it is likely that handling of the device led to off-axis forces acting on the device during insertion/withdrawal, likely causing the failure.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 DEST SLENDER 119CM6FR STR
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION (TMC); 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 11365506
• MDR Text Key: 233092381
• Report Number: 1118880-2021-00023
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00389701011547
• UDI-Public: (01)00389701011547(17)220630(10)YA22
• Combination Product (y/n): N
• PMA/PMN Number: K193125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: GS-R6ST1C12W
• Device Catalogue Number: GS-R6ST1C12W
• Device Lot Number: YA22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1