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

Model Number N/A

Device Problem Difficult to Remove (1528)

Patient Problem Great Vessel Perforation (2152)

Event Type  Injury  

Manufacturer Narrative

Age & date of birth: elderly.Date of event: week of (b)(6) 2022.Expiration date - unknown due to unknown lot number.Udi - unknown due to unknown lot number.Implanted date: device was not implanted.Explanted date: device was not explanted.Device manufacture date - unknown due to unknown lot number.The actual device was not returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record.

Event Description

The user facility reported that the sheath of the destination slender sheath involved got stuck upon removal and pulled part of the radial artery out with it.The patient was in stable condition.The procedure outcome was successful.Additional information was received on 04 apr 2022: the event occurred at the end of a coronary chronic total occlusion (cto) procedure.It was unclear if the artery was in spasm, but it is likely.The anatomy was very tortuous.The doctor stated it was difficult to track when the sheath was initially inserted.Upon removal, the doctor was not able to put in the dilator and the 0.035" wire in to assist.Anesthesia was brought in to better sedate the patient for removal.It was unclear if medical or surgical intervention was required.The md never mentioned any post-intervention.The procedure was successful, and the patient was not affected by the sheath issue.The md felt very confident that the event that occurred with the device had nothing to do with the sheath and everything to do with the patient's anatomy and his own actions.It was confirmed that there was no allegation against the r2p device and the patient's anatomy added to the difficulty.

Manufacturer Narrative

This report is being submitted as follow-up no.1 to provide additional information in section b5 and 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 since the patient was treated for a vessel occlusion post deployment per allegation.Based on the information given, the exact root cause of the event cannot be determined.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).

Event Description

Additional information was received on 26 april 2022: according to the physician, part of the radial artery came out with the sheath.It has not been confirmed if the portion of the radial artery that was pulled out was what was seen in the images provided.The images provided revealed that something was stuck onto the sheath tip.It's not certain if the sheath was wetted prior to insertion.

• 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: 14166435
• MDR Text Key: 289733082
• Report Number: 1118880-2022-00024
• Device Sequence Number: 1
• Product Code: DYB
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: GS-R6ST1C75W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: ANESTHESIA
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Female