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

Model Number N/A

Device Problem Inflation Problem (1310)

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

Event Date 01/10/2024

Event Type  malfunction  

Manufacturer Narrative

A1: patient identifier: requested, not provided, a2: age & date of birth: requested, not provided, a3: patient sex: requested, not provided, a4: weight: requested, not provided, a5: ethnicity: requested, not provided, a6: race: requested, not provided, d6a: implanted date: device was not implanted, d6b: explanted date: device was not explanted, e3: occupation: inventory.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 involved tr band wouldn't inflate and caused a minor skin tear to the patient.The procedure was a heart catheterization.No concomitant medical products were used with the involved device.Additional information was received on 12 jan 2024: there were 18ml's of air injected into the tr band when it was applied.There was no noticeable damage to the device.The patient is stable.There were no concomitant medical devices used with the tr band.The procedure was completed using an additional tr band.The sample is not infectious.

Manufacturer Narrative

This report is being sent as follow-up no.1 to update section d9, section h3, and to provide the completed investigation results.One tr band was returned to for evaluation.The sample was subject to visual analysis.No visible damage was noted on the band or balloons.9 ml of air was left in the balloons.The sample was subject to leak testing.Approximately 18 ml of air was injected into the band and the band was submerged in a water bath for approximately 30 seconds.No air bubbles were observed from the band or balloon assembly.The sample was subject to additional leak testing.Approximately 15 ml of air was injected into the band and the band was placed in its holder for 12-24 hours.After 12 hours the air was removed from the band and 14 ml of air was left in the balloon assembly.The sample passed manual leak testing.The check valve was deconstructed to check for damage or foreign matter.Upon deconstruction no foreign matter or damage was observed from the check valve.The complaint cannot be confirmed for air leakage issues because the sample passed all leak testing, and no damage or foreign matter was found in the check valve.The exact root cause could not be determined.It is unlikely the reported issue is a manufacturing 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).Based upon the inspection of the returned sample the reported event was reassessed and deemed not reportable.

• 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 ; 4103927218
• MDR Report Key: 18682748
• MDR Text Key: 335205421
• Report Number: 1118880-2024-00006
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K152525
• 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: 02/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2024
• 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
• Device Lot Number: 0000462174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2023
• 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