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

Model Number	N/A
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	11/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided due to hospital policy.A2: age & date of birth: requested, not provided due to hospital policy.A3: patient sex: requested, not provided due to hospital policy.A4: weight: requested, not provided due to hospital policy.A5: ethnicity: requested, not provided due to hospital policy.A6: race: requested, not provided due to hospital policy.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: cath lab products manager.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 available; therefore, the actual device will not be 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 tr band regular was applied to right wrist of patient after diagnostic left heart catheterization (lhc).The patient was sent back to recovery with no issues.The recovery nurse noticed large forearm hematoma formation after patient was in recovery for approximately 30mins.The nurse had noticed the tr band had migrated off the access site.She then attempted a second tr band on top of the hematoma which did not help so pressure cuff was applied.Second tr band placement on hematoma and pressure cuff.They were able to gain control of the hematoma and patient recovered with no issues.The estimated blood loss was less than 250cc.
Additional 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 closure procedural complications because a sample was not returned for assessment.Without a sample, the exact root cause cannot be determined.It is possible the band was not placed correctly initially, leading to complications resulting in a hematoma.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 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 ; 950 elkton blvd; elkton, MD 21921 ; 4103927218
• MDR Report Key: 18253428
• Report Number: 1118880-2023-00447
• Device Sequence Number: 7116483
• Product Code: DXC
• UDI-Device Identifier: 00389701011356
• UDI-Public: 00389701011356
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K213531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: TRB29-REG
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2023
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 12/02/2023
• Supplement Report FDA Received Date: 02/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown