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

Model Number	N/A
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A3a: sex: requested, not provided.A3b: gender: n/a.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.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 or Problem Description
The user facility reported that the involved tr band was inflated for hemostasis at the end of the procedure, but it completely lost pressure two minutes later while the patient was resting comfortably on the cart.The syringe was reconnected and refilled; however, upon removal of the syringe, the band immediately lost all air again.The procedure performed was a left heart catheterization (lhc).Blood loss was less than 250cc's.On 05/20/2024, additional information was provided.Another tr-band was utilized.The patient's condition is stable.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to update section d4, d9, section h3, and to provide the completed investigation results.The actual device has been returned for evaluation.One tr band and inflator were returned for assessment.The sample was subject to visual analysis.No damage or deformities were noted on the band or inflator.1ml of air was left in the band.The sample was subject to leak testing.Approximately 18ml was injected into the band and submerged in a water bath for 30 seconds.Air bubbles were observed from the check valve.The sample failed leak testing.The check valve was deconstructed to check for damage or foreign matter.Upon deconstruction, a piece of foreign matter was found.The complaint can be confirmed for air leakage issues.The cause is foreign matter in the check valve.The operations quality engineer was notified about this issue and non-conformance (nc) was initiated.Nc will contain root cause analysis and corrective actions.Review of device history record (dhr) showed there were no issues noted during the 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 hazard based risk table (hbrt).

• Brand Name: TR BAND RADIAL COMPRESSION DEVICE
• Common Device Name: 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: 19544600
• Report Number: 1118880-2024-00082
• Device Sequence Number: 7681283
• Product Code: DXC
• UDI-Device Identifier: 00389701011356
• UDI-Public: (01)00389701011356(17)260401(10)0000429293
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K152525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2026
• Device Model Number: N/A
• Device Catalogue Number: TRB24-REG
• Device Lot Number: 0000429293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2024
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 06/15/2024
• Supplement Report FDA Received Date: 08/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 111 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White