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

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/19/2023

Event Type  malfunction  

Event Description

The user facility reported that the cath lab had the involved tr band lose air after being inserted into a patient, causing arterial bleeding.The patient was in stable condition.The device didn't work due to the malfunction; however, the case was finished.The procedure outcome was successful.The event occurred post-treatment.

Manufacturer Narrative

D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: materials manager.The actual device is not available for returned; therefore, an evaluation of the actual device will not be conducted.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 report that during an internal review it was found and confirmed that the reported event submitted under this mdr is a duplicate report and was inadvertently submitted.For details on the event reported please see mdr 1118880-2023-00278.

• Brand Name: TR BAND RADIAL COMPRESSION DEVICE
• 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: 17149209
• MDR Text Key: 317459475
• Report Number: 1118880-2023-00287
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00389701012469
• UDI-Public: 00389701012469
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/17/2023

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: TRB24-REG-01
• Device Lot Number: 0000326994
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/19/2023
• Initial Date FDA Received: 06/17/2023
• Supplement Dates Manufacturer Received: 11/13/2023
• Supplement Dates FDA Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2023
• 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
• Patient Outcome(s): Required Intervention