MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION (TMC) 24CM TRANSRADIAL BAND(REGULAR); CLAMP, VASCULAR

Model Number N/A

Device Problem Gas/Air Leak (2946)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/06/2021

Event Type  Injury  

Manufacturer Narrative

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 device history record (dhr) review determined that the device was in a conforming state when released from terumo control.There is no indication that any manufacturing issues may have led to this event.Currently no action is recommended since this risk evaluation is within the predetermined limits in the failure mode and effects analysis (fmea).Sample was not available.

Event Description

The user facility reported that the involved tr band deflated too quickly.Manual pressure was not held.The tr band was defective, the tr band had to be taken off and manual pressure was held instead.The patient impact was ok.The event occurred post-treatment.The estimated blood loss was less than 250cc¿s.The patient was discharged.The procedure outcome was successful.The patient was not injured during the event and medical or surgical intervention was not required.There were no other devices or equipment used with the reported product.Additional information was received on 20 sept 2022: the procedure for the patient prior to the application of the tr-band was an angioplasty.The device deflated immediately after inflation.The patient was in stable condition and the event that occurred did not cause any injury to the patient.Blood loss was less than 10mls.

• Brand Name: 24CM TRANSRADIAL BAND(REGULAR)
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION (TMC); 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO MEDICAL CORPOTATION; 950 elkton blvd; elkton MD 21921
• Manufacturer Contact: gina digioia ; 950 elkton blvd; elkton, MD 21921 ; 6402040886
• MDR Report Key: 15601596
• MDR Text Key: 301729472
• Report Number: 1118880-2022-00076
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00389701011349
• UDI-Public: 00389701011349
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K152525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2023
• Device Model Number: N/A
• Device Catalogue Number: TRB24-REG
• Device Lot Number: 0000052644
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention