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

Model Number N/A

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.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.A review of the device history record of the product code/lot# combination was conducted with no findings.

Event Description

Terumo medical received a user facility medwatch report #1900450000-2019-8023.The event description states: as case ended, the tr band was applied to the site of the sheath in the radial artery.The tr band was inflated to normal pressure.At this time, the balloon on the band burst while on the patient.The original procedure was left heart catheterization (lch), ffr and coronary stent placement.

Manufacturer Narrative

This report is being submitted as follow up no.1 to correct the b4 date and to provide the completed investigation results.In the initial report it was reported that the date of this report was 15-jan-2020 however the correct date is (b)(6)2020.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: 9595755
• MDR Text Key: 199313094
• Report Number: 1118880-2019-00372
• 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: User Facility
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: N/A
• Device Catalogue Number: TRB29-LRG
• Device Lot Number: XH31
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 90