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

Model Number	TRB24-REG
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Hematoma (1884)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided a2: age & date of birth: requested, not provided a3a: sex: requested, not provided a3b: gender: requested, not provided a4: weight: requested, not provided a5: ethnicity: requested, not provided a6: race: requested, not provided b3: date of event: requested, unknown d6a: implanted date: device was not implanted d6b: explanted date: device was not explanted e3: occupation: purchasing the actual device is not available for return; therefore, an evaluation of the actual device was unable to be conducted.The complaint cannot be confirmed for air leakage issues because a sample was not returned for assessment.Without a sample, the exact root cause cannot be determined.Review of device history record (dhr) showed there were no issues noted during the manufacture of the product that could have contributed to this complaint condition.Currently, no action is recommended since the risk evaluation is within the predetermined limits in the hazard based risk table (hbrt).
Event or Problem Description
The user facility reported that when the tr band was inflated, it did not stay inflated and caused a hematoma under the patient's skin.Additional information was received on 31oct2024: the procedure for the patient prior to the use of the tr band was a heart catheterization.Approximately 10-14mls of air were injected into the tr band.Sheath and catheters were used during the heart catheterization procedure.The tr band lost air approximately three minutes after the initial inflation.Hemostasis was achieved by using a tr band from another lot number, the initial tr band was removed my holding manual compression and then applying the new band.They treated the hematoma with compression at the site and may have added protamine.The size of the hematoma was small since it was noted right away, there was only minor swelling.The estimated blood loss was less than 250cc.There was no noticeable damage to the device.The patient was stable.

• Brand Name: TR BAND RADIAL COMPRESSION DEVICE
• Common Device Name: 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: stephanie handy ; 950 elkton blvd; elkton, MD 21921 ; 9499890491
• MDR Report Key: 20800171
• Report Number: 1118880-2024-00185
• Device Sequence Number: 17850701
• Product Code: DXC
• UDI-Device Identifier: 00389701011356
• UDI-Public: (01)00389701011356(17)261001(10)0000582946
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K152525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/27/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2026
• Device Model Number: TRB24-REG
• Device Catalogue Number: TRB24-REG
• Device Lot Number: 0000582946
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown