MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION R2P¿ DESTINATION SLENDER¿ GUIDING SHEATH

Model Number N/A

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Hemorrhage/Bleeding (1888); Foreign Body In Patient (2687); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 06/27/2023

Event Type  Injury  

Event Description

The user facility reported that the involved 75cm destination slender (ds) broke off when trying to remove from the patient (right radial).Patient was rushed to the operating room to have surgical intervention.Patient had severe radial spasm and was put under general anesthesia when sheath was unable to be removed.Estimated blood loss was less than 250 ccs.Removal of the ds that broke inside of the patient was performed.The piece was removed from the arm.The patient is doing well after surgical removal.The event occurred intra-operative.Additional information was received on 06 jul 2023: the patient has had multiple stents in place already.A 6 fr glidesheath slender was used along with a command wire, jr4 and 6 fr guide, then switched to our 6 fr 75 cm destination slender during intervention (which was successful).However, post intervention the patient had severe spasms in her right radial, was given nitro and even put under general when the physician couldn't remove the destination slender.According to the physician, the destination slender coils started to stretch and broke off (in two) around the patient's biceps area.Tried to snare the piece of ds that was left in the patient with a balloon but wasn't successful.Also, went in with a trailblazer microcatheter to try and drag back but wasn't successful either.The patient was then treated in the operating room and the piece was removed with a small surgical incision.Patient is doing well now.Additional information was received on 06 jul 2023: the patient's radial artery was spasming with initial access.It continued to worsen when the ebu guide was placed.The doctor used nitro & heparin; calcium channel blockers (such as verapamil) was not used in the radial cocktail.When the spasm was seen the ebu guide, decided to use the destination slender.They completed the intervention, however, when the sheath was being removed the tried to re-insert the dilator prior to the sheath removal.The screw on the valve became loose during removal.The tip of the sheath was in the bicep, the area of spasm was in the mid forearm.

Manufacturer Narrative

D4: lot number: requested, unknown.D4: expiration date: unknown due to unknown lot number.D4: udi: unknown due to unknown lot number.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.H4: device manufacture date: unknown due to unknown lot number.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record.The actual device is not available for returned.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.

Manufacturer Narrative

This report is being sent 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 sheath separation.Based on the photos provided by the account, the sheath unraveled during removal from the patient.Without a sample, the exact root cause could not be determined.The likely root cause is the patient spasm was not alleviated completely before attempted removal of the sheath.Review of device history record (dhr) cannot be completed due to the unknown lot number.Currently no action is recommended since this risk evaluation is within the predetermined limits in design failure mode and effects analysis (dfmea).

• Brand Name: R2P¿ DESTINATION SLENDER¿ GUIDING SHEATH
• Type of Device: GUIDING SHEATH
• 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: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 17410270
• MDR Text Key: 319956634
• Report Number: 1118880-2023-00377
• 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: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 06/28/2023
• Initial Date FDA Received: 07/27/2023
• Supplement Dates Manufacturer Received: 08/09/2023
• Supplement Dates FDA Received: 09/08/2023
• 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: CARAVAL; GENERAL ANESTHESIA; GRAND SLAM WIRE; NITRO; RUBICON
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female