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 Pain (1994); Discomfort (2330)

Event Date 04/01/2023

Event Type  Injury  

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.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: quality nurse specialist iii.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 was not 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 a patient on (b)(6), 2023 received a tr-band 2 device to achieve patent hemostasis after a regular heart catheterization.The patient ended up getting compartment syndrome and required a fasciotomy to combat the compartment syndrome.

Manufacturer Narrative

This report is being sent as follow-up no.1 to provide additional information to sections a2, a3,a4, a5, a6 and b5.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.A4: weight: 92.8kg.

Event Description

Additional information was received on 25aug2023: right radial artery procedure.No other devices used with the tr band 2.Unsure if the sheath withdrawn before application of the tr band 2.Normal process is to remove the sheath as the tr band is being applied.This patient did not leave the cath lab with a sheath in place.Unknown amount of air was injected into the tr band 2 initially.Unknown if the tr band 2 the cause of the compartment syndrome.The complication did apply in extremity on which tr band was applied.Additional information was received on 12sept2023: the patient developed a hematoma at the site and underwent a fasciotomy.Additional information was received on 21sept2023: the band did not deflate while in use nor did it fail to hold air.

Manufacturer Narrative

This report is being sent as follow-up no.2 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 tr band 2 device, it is unlikely the compartment syndrome harm can be related to the use of the tr band 2.Review of devcie 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).

Manufacturer Narrative

This report is being sent as follow-up no.3 to provide a correction to section b3 and to provide additional information in sections b3, b5, g2.Also to attach the related medwatch report.

Event Description

Terumo medical received an fda medwatch report # mw5147998.The event description states: "patient had urgent cath performed for nstemi (non-st-elevation myocardial infarction) with right radial access and iabp intra-aortic balloon pump) insertion (b)(6) 2023.Found severe cad (coronary artery disease) and required ct (computed tomography) surgery consult.Right radial access site had tr (terumo radial) band applied.Site developed hematoma which extended up into upper arm.Taken to cvor (cardiovascular operating room) for fasciotomy due to compartment syndrome.Tr band has received a recent redesign, but functionality is to remain the same.Education provided for staff prior to replacement.Medical procedural staff reporting issues with application and maintenance of new bands.Rep made aware and back onsite for more education and investigation.".

• 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: 17419752
• MDR Text Key: 320036749
• Report Number: 1118880-2023-00375
• 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: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: TRB24-REG-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2024
• 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
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White