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

Model Number	N/A
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided.A2: date of birth: requested, not provided.A3b: gender: n/a.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E2: health professional: unknown.E3: occupation: clinical resource nurse.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 procedure performed was a coronary percutaneous coronary intervention (pci) via right radial access.At end of the procedure, the physician cleaned the site and applied a large tr band.The band was inflated, and introducer sheath was removed.Upon removal of the band syringe, the balloons appeared to immediately deflate, and bleeding started.An attempt was made to reinflate balloons; however, they would not hold air.Manual pressure was held, and a new tr band was applied and inflated without issue.The blood loss was less than 250cc.The reported event did not result in patient injury and/or require medical or surgical intervention.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 20jun2024: the kab did not record the amount of air in the tr band.A 6 french glidesheath slender was used in the access site.The tr-band was noted to be losing air immediately after removing the syringe from initial inflation, band lost air and bleeding was noticed.There was no noticeable damage to the device.The patient was stable, and recovery was uneventful.The bleeding was noted immediately by the physician.There were no issues noted with recovery.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide a correction to section d4: udi and section e1: phone number, to update section h3, and to provide the completed investigation results.One tr band, inflator and packaging were returned to terumo medical corporation for assessment.The sample was subject to visual analysis.There were no damage or deformities noted on the band or inflator.There is 9.5ml of air left in the band.The sample was subject to leak testing.Approximately 18ml of air was injected into the band and submerged in a water bath for 30 seconds.Air bubbles were observed from the inflation balloon to check valve seal.The sample failed leak testing.The sample was placed under a microscope to look at the location of the leak.Upon microscopic inspection, there is a tear on the seal of the inflation balloon to check valve.The complaint can be confirmed for air leakage issues.The cause is a tear on the inflation balloon to check valve seal.The operations quality engineer was notified about this issue and a nonconformance (nc) was initiated.The nc will contain root cause analysis and corrective actions.Review of the 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: 19712764
• Report Number: 1118880-2024-00102
• Device Sequence Number: 18293779
• Product Code: DXC
• UDI-Device Identifier: 00389701011356
• UDI-Public: (01)00389701011356(17)260901(10)0000551682
• Combination Product (Y/N): N
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2024

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: 09/01/2026
• Device Model Number: N/A
• Device Catalogue Number: TRB29-LRG
• Device Lot Number: 0000551682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2024
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 212 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White