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 Pain (1994)

Event Date 10/22/2020

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 the doctor performed diagnostic angio on the patients iliac and both legs.Access was relatively easy, and access was gained on first attempt under ultrasound.Angio was performed through radial sheath and 125 b.S.Pigtail.Concentric blockage was noted in the common femoral artery (cfa).Prior to advancing the r2p sheath, vessel size was verified and stated by the physician to be 2 mm.This was confirmed post procedure to be 2.1 mm.Upon advancement of the sheath, the patient was having pain in the wrist upon advancement.Once in place, patient was comfortable and rested peacefully through the procedure.Upon removal of the sheath, the patient expressed very high levels of pain and the physician encountered much resistance due to spasm.Verapamil and demerol were given to the patient intra-arterial (ia) while the sheath was still in the aorta (ao).Once the sheath was determined to be in the distal subclavian/upper arm, the physician started giving verapamil and nitro via the sheath.Additionally, we attempted hyperemia via blood pressure cuff as well as warm compresses and additional sedation.It took about 30 minutes for sheath removal at which time the physician was able to gain momentum of removal and sheath with purposefully removed with manual pressure and a tr band was successfully placed post removal.Once removed the patient was comfortable and expressed no pain.The patient was stable, and the procedure was completed successfully.The estimated blood loss was less than 250cc.

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 withdrawal difficulty.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: 10857921
• MDR Text Key: 216905776
• Report Number: 1118880-2020-00291
• 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,health
• Type of Report: Initial,Followup
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: N/A
• Device Catalogue Number: GS-R6ST1C12W
• Device Lot Number: XG04
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DEMEROL; R2P METACROSS BALLOONS; VERAPRIL; DEMEROL; R2P METACROSS BALLOONS; VERAPRIL
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Weight: 70