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 05/06/2019

Event Type  malfunction  

Manufacturer Narrative

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 has not been 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 and complaint files.

Event Description

The user facility reported that a patient was examined one hour post application of a tr band in preparation to deflate the band.It was then noticed to only have 4cc's of air left from the initial 11cc's placed.There was no blood loss, however, there was a small hematoma.The procedure was completed successfully.The patient was reported to be in stable condition and was discharged without issue.

Manufacturer Narrative

This report is being submitted as follow up no.1 to update the d10 and h3 section.In the initial report it was reported that the device was available for returned however the device is no longer available.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.3 to provide additional information to the g3 and b5 section.

Event Description

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

Event Description

Additional information was received 28august2019: the procedure being performed was a coronary angiogram.The hematoma was not deemed serious enough to treat.

Manufacturer Narrative

This report is being submitted as follow up no.2 to provide the additional information in the b5 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.

• Brand Name: TR BAND
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 8771306
• MDR Text Key: 151854765
• Report Number: 1118880-2019-00164
• 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,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?: No
• 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