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

Model Number N/A

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

Patient Problems Hematoma (1884); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

A1: patient identifier: unknown.A2: age & date of birth: unknown.A3: patient sex: unknown.A4: weight: unknown.A5: ethnicity: unknown.A6: race: unknown.B3: date of event: unknown.D4: lot number: requested, unknown.D4: expiration date: unknown due to unknown lot number.D4: udi: unknown due to unknown lot number.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: unknown.H4: device manufacture date: unknown due to unknown lot number.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record.The actual device is not available for return.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 cath lab manager at (b)(6) hospital read a national press ganey report that stated terumo had issues with the new version of tr bands (tr band 2).Patient safety organization.Safety alert: radial compression device.(b)(6), 2023 12:10 pm.(b)(6).Situation: a press ganey patient safety organization member has identified that a serious safety event has occurred while using a new version of the terumo tr band® radial compression device.This issue has been reported to the manufacturer and the fda.Background: according to the healthcare organization, terumo has recently made changes to a radial compression device called the tr band®.This device is used for right radial sites after a cardiac catheterization.The changes involved: · markings on the band · how the syringe is attached additionally, care providers reported that the new band requires more air and that the balloon does not inflate as well as with the former version.According to the press ganey pso member who alerted us about this issue, the manufacturer has been alerted and has communicated that they are reverting back to the original design.Assessment: in this press ganey pso member organization, patient developed compartment syndrome after using this device.Compartment syndrome is a painful condition that occurs when pressure within the muscles builds to dangerous levels.This pressure can decrease blood flow, which prevents nourishment and oxygen from reaching nerve and muscle cells.Compartment syndrome can require surgical intervention that involves extensive healing for the patient.Hro-based recommendations : preoccupation with failure - clinicians should be on the lookout for pain and hematomas where radial compression bands are used.- perform inventory of tr band® radial compression device to determine if you are using the old design or the new one.Routinely reinspect to note if anything has changed.Have supply chain personnel set an alert to warn the nursing departments if they shift from the old model to the new one.Resources: be sure to read the latest blog on addressing replacement supplies using high reliability organizing by (b)(6), bsn, cpps, senior manager, strategic consulting at press ganey.In this piece, (b)(6) shares important considerations any time new and different equipment and supplies are introduced into care.Terumo tr band® radial compression device.Bahl s, dheendsa a, ramlal n, et al.Trans-radial band compression device related complications: food and drug administration database analysis involving manufacturer and user facility device experience.J am coll cardiol.2023 mar, 81 (8_supplement) 1003.Doi.Org/10.1016/s0735-1097(23)01447-x.------------------------------ (b)(6).------------------------------.

Manufacturer Narrative

This report is being sent as follow-up no.1 to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The complaint cannot be confirmed for procedural complications because a sample was not returned for assessment.Without a sample, the exact root cause cannot be determined.Without a failure or malfunction of the device, it is unlikely the tr band 2 was the cause of the compartment syndrome.Review of device history record (dhr) cannot be completed due to the unknown lot number.Currently no action is recommended since this risk evaluation is within the predetermined limits in the hazard based risk table (hbrt).

• 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: 18027261
• MDR Text Key: 326795050
• Report Number: 1118880-2023-00417
• Device Sequence Number: 1
• Product Code: DXC
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 10/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2023
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/23/2024
• 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
• Patient Outcome(s): Required Intervention; Other