MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION TR BAND; CLAMP, VASCULAR

Model Number N/A

Device Problems Inflation Problem (1310); Material Puncture/Hole (1504); Gas/Air Leak (2946)

Patient Problems Bruise/Contusion (1754); Hematoma (1884); Pain (1994); Numbness (2415); Diminished Pulse Pressure (2606); Swelling/ Edema (4577)

Event Date 05/11/2023

Event Type  Injury  

Manufacturer Narrative

A2: date of birth: requested, not provided.A4: weight: 53.1 kg.A5: ethnicity: requested, not provided.D6a: implanted date: device was not implanted.D6b: 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.

Event Description

The user facility reported that the tr band was applied after a successful bland liver embolization.The sheath was removed and 20cc of air was injected into the tr band.There was 5cc of air removed to achieved hemostasis.The scrub tech noticed that the access site was bleeding a minute after hemostasis.When applying more air, it was noted that the balloon would not inflate.Manual compression was applied to stop the bleeding while a second tr band was applied to maintain hemostasis.The patient had bruising and a hematoma around the access site.The patient was in stable condition.The estimated blood loss was less than 250cc.The patient required medical intervention.The event occurred post-treatment.The procedure outcome was completed successfully.Additional information was received on 07 jun 2023: manual compression was applied to treat the small hematoma until a second band was applied.The hematoma size was documented as small.The patient experienced swelling, pain, numbness, and had a faint pulse.The scrub tech did note that there was a small hole in the balloon.Nothing was placed under the balloon to clean the access site.There was a small hematoma immediately after placing the tr band due to malfunctioning of the band.A new tr band was applied, and the hematoma was reduced.Upon arrival to pacu, hand was dusky, and there was no pulse detected in the left thumb.No radial pulse with doppler.Cap was refilled less than 3 seconds in the left thumb.1ml relieved, then tr band was removed.Hand returned to baseline.Damage to the tr-band was described that the tr band for radial access malfunctioned and the balloon would not blow up.Patient started developing a hematoma in the left radial.Additional information was received on 23 jun 2023: terumo medical received an fda medwatch report # mw5118427.The event description states: tr (terumo radial) band for radial access malfunctioned and balloon would not blow up.Patient started developing hematoma in left radial.New tr band was applied.Later it was discovered that the tr band had hole in the balloon.

Manufacturer Narrative

This report is being sent as follow-up # 1 to provide the completed investigation results.The actual device has not been returned; therefore, an evaluation of the actual device was unable to be conducted.When the device is returned the complaint will be reopened.The complaint can be confirmed for air leakage issues based on the sample photos provided by the account.The sample is leaking from the inflation balloon to check valve seal.Without a sample, the exact root cause cannot be determined.It is possible there is a tear or incomplete seal on the inflation balloon to check valve that led to the leak the user experienced.The operations quality engineer was notified about this issue.Review of device history record (dhr) showed there were no issues noted during manufacture of the product that could have contributed to this complaint condition.Currently no action is recommended since this risk evaluation is within the predetermined limits in the design failure mode and effects analysis (dfmea).

• Brand Name: TR BAND
• Type of Device: CLAMP, VASCULAR
• 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: 17244360
• MDR Text Key: 318311911
• Report Number: 1118880-2023-00329
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00389701011349
• UDI-Public: 00389701011349
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2023
• 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: TRB24-REG
• Device Lot Number: 0000331755
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: MW5118427
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 53 KG
• Patient Race: White