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

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problem Hematoma (1884)

Event Date 05/08/2019

Event Type  Injury  

Manufacturer Narrative

Patient identifier - requested, not provided.Age & date of birth - late 50's.Weight - requested, not provided.Ethnicity - requested, not provided.Race - requested, not provided.Expiration date - unknown due to lot number being unknown.Udi - unknown due to lot number being unknown.Implanted date: device was not implanted.Explanted date: device was not explanted.Device manufacture date - unknown due to lot number being unknown.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.For this reason, evaluation code 11 has been referenced in the conclusions.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record and complaint files.

Event Description

The user facility reported that the tr band deflated slowly over the course of an hour, so that by the time the nurse came to remove air for the first time there was only 5cc left in the band, from a charted volume of 12cc.A hematoma was observed, the tr band was removed and a second tr band was placed for 30mins, followed by manual compression for 15mins.The patient was discharged and was in stable condition with a small hematoma.The procedure was completed successfully with no other issues.

Event Description

Additional information was received 28august2019: the procedure being performed was a coronary angiogram.The hematoma was not treated.The estimated blood loss was 10cc's.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the additional information in the section completed investigation results.The evaluation of the actual device could not be conducted due to the device not being returned.With no device return, the exact cause of the reported event cannot be definitively determined based on the available information.

Event Description

Additional information was received on 13august2019.Per cmdsnet report number: (b)(4).The event description states: " that tr bands spontaneously deflated.".

Manufacturer Narrative

This report is being submitted as follow up no.2 to provide additional information.

• Brand Name: TR BAND
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 8771305
• MDR Text Key: 150401105
• Report Number: 1118880-2019-00166
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention