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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pseudoaneurysm (2605)

Event Date 12/11/2020

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.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.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 they accessed the left radial artery after a positive barbeau test.They treated the left distal superficial femoral artery (sfa) with atherectomy and bare metal stent.A pseudoaneurysm was noted, however the timing was not specified.The patient was reported to be in stable condition and the procedure outcome was stabilized.Additional information was received on 15jan2021.The user facility reported that the adverse event (ae) was a left radial artery pseudoaneurysm that was found at the one month follow up visit on a duplex ultrasound.Additional information was received on 19jan2021.The follow up was on 12jan2021.Additional information was received on 21jan2021.The patient is stable, an angio was performed last week with left radial artery (ra) access.The doctor reviewed the images and stated it was ectatic and not an aneurysm.

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 cannot be confirmed for procedural complication since the device was used without issue and the vessel was found to be ectactic.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 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
• MDR Report Key: 11303418
• MDR Text Key: 231307905
• Report Number: 1118880-2021-00012
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00389701011547
• UDI-Public: 00389701011547
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: N/A
• Device Catalogue Number: GS-R6ST1C12W
• Device Lot Number: XL18
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CROSTELLA; DIAMONDBACK; GLIDESHEATH SLENDER; MISAGO; NAVICROSS
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 75