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

Model Number N/A

Device Problems Inflation Problem (1310); Material Puncture/Hole (1504)

Patient Problems Hematoma (1884); Blood Loss (2597)

Event Date 10/03/2019

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Healthcare professional - unknown.The actual device has been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record of the product code/lot# combination was conducted with no findings.

Event Description

The user facility reported that the tr band was found to have a hole in it when trying to inflate it with the syringe.Additional information was received on 15oct2019.The type of procedure that was performed being performed was a left heart catheterization.The location of the hole could not be seen by the account.The tr band was not holding any air.The patient was stable.The procedure was completed by using a different tr band.The estimated blood loss was less than 250cc.Additional information was received on 21oct2019.Per the account it appeared there was a puncture in the tr band "pillow" which subsequently led to bleeding and the patient developed a significant hematoma.

Manufacturer Narrative

This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.One used large tr band assembly was returned for product evaluation.Visual inspection revealed that the communication port which attaches the two balloons was ripped apart completely.Leak testing was attempted to be performed on the device.However, due to the communication port being fully open the balloons were not able to be inflated.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.Based on the investigation results it is likely that the balloons were attempted to be separated prior to inflating which could have caused the reported event.However, 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: 9261952
• MDR Text Key: 164487922
• Report Number: 1118880-2019-00306
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00389701011356
• UDI-Public: 00389701011356
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: N/A
• Device Catalogue Number: TRB29-LRG
• Device Lot Number: XC28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Date Manufacturer Received: 11/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Weight: 107