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	02/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: cath lab manager.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.
Event or Problem Description
The user facility reported that post percutaneous coronary intervention (pci), a tr band was placed to close the radial artery.It was reported that the seal on the one-way valve was leaking, and the band was not able to hold air.The tech grabbed another tr band and was able to achieve hemostasis with the second tr band.There was no harm to the patient.The estimated blood loss was less than 250cc's.No patient injury and/or require medical or surgical intervention.The event occurred intra-operative.There is not a direct allegation that the reported device caused or contributed to patient injury and/or need for medical intervention.Additional information was received on 23 feb 2024: 15 ml's of air was injected into the syringe.There was a 6 fr glide sheath in the right radial artery.Tr band lost air as soon as the syringe was disconnected from tr band.There was no noticeable damage to the band.The patient was stable, held manual pressure and applied a different tr band to the site.After replacing the tr band, air was injected into band while under the saline.The band stayed inflated until disconnecting the syringe and air came back through the valve.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to provide the completed investigation results.One tr band and inflator were returned for evaluation.The sample was subject to visual analysis and 0ml of air was found in left in the balloons.No damage or deformities are noted on the band or inflator.The sample was subject to leak testing.Approximately 18ml of air was injected into the balloons and the band was submerged in a water bath for approximately 30 seconds to check for air bubbles.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 foreign matter was found in the check valve.The complaint can be confirmed for air leakage issues.The cause is foreign matter in the check valve.The operations quality engineer was contacted, and non-conformances (nc) was initiated for this issue.Nc will contain root cause analysis and corrective actions.Review of device history record 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).

• 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: 18823253
• Report Number: 1118880-2024-00018
• Device Sequence Number: 20704441
• Product Code: DXC
• UDI-Device Identifier: 00389701011356
• UDI-Public: 00389701011356
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 03/02/2024

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: 05/01/2026
• Device Model Number: N/A
• Device Catalogue Number: TRB29-LRG
• Device Lot Number: 0000455831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2024
• Supplement Report FDA Received Date: 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2023
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 103 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White