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

Model Number N/A

Device Problem Material Separation (1562)

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

Event Date 10/05/2020

Event Type  malfunction  

Manufacturer Narrative

Expiration date : unknown due to unknown product code and lot number.Udi: unknown due to unknown product code and lot number.Implanted date: device was not implanted.Explanted date: device was not explanted.Device manufacturer date: unknown due to unknown product code 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 lot number was not provided by the user facility, which prevented a meaningful review of the device history record.

Event Description

Terumo medical received a user facility medwatch report # (b)(4).The event description states: "an rn was removing air from the tr band device according to protocol.When she inserted the tr band inflater syringe into the balloon port, the tip of the syringe broke off in the balloon port.This resulted in the immediate loss of air/deflation along with loss of hemostasis at the at the radial procedure site, with bleeding.The rn held manual pressure and requested assistance from the charge rn to obtain a new tr band from the cath lab." the original intended procedure was: "nurse removing air from tr band." "unlikely that pt.Information had an effect on this event." what problem did the user have: "device failed".Additional information was received on 16nov2020."rn held manual pressure and requested assist from the chg rn to obtain a new tr band from cath lab." the patient did not suffer harm from the tip breaking off and the temporary loss of hemostasis.The patient's condition was stable.

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 can be confirmed for mechanical damage.Based on the information given, the exact root cause of the event cannot be determined.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
• MDR Report Key: 10895721
• MDR Text Key: 247663906
• Report Number: 1118880-2020-00304
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• PMA/PMN Number: K152525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 127