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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/04/2023

Event Type  Injury  

Manufacturer Narrative

Catalog number: requested, unknown.Lot number: requested, unknown.Expiration date: unknown due to unknown catalog and lot combination.Udi: unknown due to unknown catalog and lot combination.Implanted date: device was not implanted.Explanted date: device was not explanted.Initial reporter name: multiple techs.Occupation: xray tech.Device manufacture date: unknown due to unknown catalog and lot combination.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record.The actual device was not available; therefore, the actual device will not be returned for evaluation.The complaint can be confirmed for air flow issues because the cause of the issue was discussed with the clinical specialist.Without a sample, the exact root cause could not be determined.The likely root cause is the user is not injecting enough air initially, leading to bleeding at the access site.Review of the device history record (dhr) could not be completed due to the lot number being unknown.Currently no action is recommended since this risk evaluation is within the predetermined limits in the hazard based risk table (hbrt).

Event Description

The user facility reported that the tr band 2 involved was applied as usual and achieved hemostasis.After the patient was transferred to a stretcher from the procedure table, it was noticed that a hematoma was forming proximal to the tr band 2.Pressure was applied to reduce the hematoma then a 2nd tr band was applied proximal to the first device and inflated with air.The patient was sent to the recovery floor and standard protocol was followed.The blood loss was less than 250cc's.The patient was in stable condition, recovered, and discharged home.The procedure outcome was as desired.Additional information was received on (b)(6) 2023.Bleeding at site was observed while the patient was still in the procedure room and between the time the band was applied, and the patient was transferred to transport stretcher.It was unclear if there was air leakage or insufficient air placed in band, or if the band migrated from its original placement during transfer.The 2nd tr band resolved the hematoma.No additional intervention was reported.

• 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: 16833438
• MDR Text Key: 314200342
• Report Number: 1118880-2023-00071
• Device Sequence Number: 1
• Product Code: DXC
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2023
• 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: SECOND BAND PLACED PROXIMAL TO FIRST.
• Patient Outcome(s): Required Intervention; Other