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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/28/2020

Event Type  malfunction  

Manufacturer Narrative

Expiration date - unknown due to unknown lot number.Udi - unknown due to unknown lot number.Implanted date: device was not implanted.Explanted date: device was not explanted.Device manufacturer date - unknown due to unknown lot number.The actual device has been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record.

Event Description

The user facility reported that the distal tip of a tr band syringe broke off inside the tr band valve and became stuck.There were no issues relative to the patient.The patient's condition was stable.The procedure was successful.There was no patient injury, medical/surgical intervention required.Additional information was received on 20nov2020.The procedure prior to use of the tr band was a cardiac catheterization.The event did not impact hemostasis or the patient, in general.

Event Description

Additional information was received on 11jan2021.The user stated that the inflator tip broke and then the tip was stuck inside the check valve.The customer could not confirm if the breakage was a result of the inflator getting stuck inside the valve.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide additional information in section b5, to update section h3, and to provide the completed investigation results.One 24 cm tr regular band assembly and its inflator was returned for product evaluation.The inflator was returned with the tip broken off.Visual inspection of the check valve revealed that the tip of the inflator was stuck inside the check valve.The inflator tip could not be removed from the check valve.No further damage or anomalies were noted on the inflator or the tr band.The proximal portion of the breakage was smooth and partially whitened, which could have been caused by the resin material being stretched during the breakage.Based on this evidence of possible stretching, it can be inferred that the fracture on this segment had developed slowly.The complaint can be confirmed for mechanical damage based on the damage noted on the return sample.Based on the investigation result, it is likely that the inflator was subjected to an instantaneous shock force on the tip component and the tip was partially fractured.Subsequently, when it was inserted into the check valve, it was subjected to a bending force at the joint, resulting in the breakage.The device was in a conforming state when released from terumo control.There is no indication that any manufacturing issues may have led to this event.Currently no action is recommended since this risk evaluation is within the predetermined limits in the fmea.

• Brand Name: TR BAND
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 10934300
• MDR Text Key: 219370990
• Report Number: 1118880-2020-00315
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• PMA/PMN Number: K152525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: TRB24-REG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Date Manufacturer Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1