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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Date 05/15/2023

Event Type  Injury  

Event Description

Closure procedural complicationthe user facility reported that the patient developed an immediate hematoma after placing the tr band 2.The tech applied a second trb 2 proximal and was able to relieve the hematoma.The patient was in stable condition and the procedure was successful.The blood loss was less than 250cc's.There was no medical or surgical intervention required.Additional information was received on (b)(6) 2023: fourteen (14) ml of air was injected into the tr band initially.There was no noticeable damage to the device.The device was not manipulated before use in any way during pre-use or during storage.The product was stored in a cabinet in plastic bin prior to use.The procedure prior to the tr band application was a percutaneous coronary intervention (pci).It was unsure how large (approximately) the hematoma was.

Manufacturer Narrative

E3: occupation: tech.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.

Manufacturer Narrative

This report is being submitted as follow-up no.1 to correct section g4 (510k #) and 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 can be confirmed for closure procedural complications.Without a sample, the exact root cause cannot be determined.The complaint was discussed with the chief medical officer and there is not enough information provided to determine if the device failed and caused the bruising and hematoma.Based on the photos provided by the account it is possible the band was not placed correctly initially, leading to incomplete hemostasis.Review of device history record (dhr) cannot be completed due to the unknown lot number.A non-conformance (nc) was initiated due to the increase in risk level.

• Brand Name: TR BAND
• 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: 17040354
• MDR Text Key: 316381907
• Report Number: 1118880-2023-00203
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2023
• 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: 07/05/2023
• 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
• Treatment: TRB2 PROXIMAL TO THE TRB2
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Sex: Female