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 Type  Injury  

Event Description

Per literature review: indian heart journal: comparison of radial versus femoral access using hemostatic devices following percutaneous coronary intervention.Patients were brought in for percutaneous coronary intervention (pci), with those undergoing radial access all having 6f sheath, with radial closure with tr band.Patients ambulated one hour post procedure.There was no device failure or instances of major bleeding or vascular complications.Mean ambulating time was one hour.Duration of hospital stay was 1.78 days.Oozing and localized hematoma not requiring medical or surgical intervention.

Manufacturer Narrative

Patient identifier - unknown.Age & date of birth - average age 58 years old (range 50-65 years old).Patient sex - 360 males and 59 females.Weight - unknown.Ethnicity - unknown.Race - unknown.Date of event - unknown lot number - unknown.Expiration date - unknown due to unknown catalog number and lot number.Udi - unknown due to unknown catalog number and lot number.Implanted date - device was not implanted.Explanted date - device was not explanted.Contact - unknown.Address - unknown.Telephone number - unknown.Healthcare professional - uknown.Occupation - unknown.Device manufacture date: unknown due to unknown catalog number and lot number.The actual device was not returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.The production catalog number and lot number were not provided by the user facility, which prevented a meaningful review of the device history record.

Manufacturer Narrative

This report is being submitted 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 since the device was not available for evaluation.The exact root cause cannot be determined.The dhr could not be reviewed since the device was not available for evaluation.Currently no action is recommended since this risk evaluation is within the predetermined limits in the fmea.

• 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: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 14069357
• MDR Text Key: 293697165
• Report Number: 1118880-2022-00022
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K152525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/22/2022
• 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
• Patient Outcome(s): Other