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

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2019

Event Type  malfunction  

Manufacturer Narrative

Patient identifier - requested, not provided.Age & date of birth - requested, not provided.Sex - requested, not provided.Weight - requested, not provided.Ethnicity - requested, not provided.Race - requested, not provided.Implanted date: device was not implanted.Explanted date: device was not explanted.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 balloon did inflate; however, another tr band had to be used.The second tr band had a successful placement.The patient was stable.The procedure outcome was successful.Additional information was received (b)(6) 2019: the balloon on the tr band inflated, but would not and did not remain inflated causing the band to fail to provide hemostasis.The staff pulled another tr band large from the same box.The procedure performed was a coronary intervention.The second tr band did perform correctly.Hemostasis was obtained with no complications by the second tr band.

Manufacturer Narrative

This report is being submitted as follow up no.1 to update the and to provide the completed investigation results.One tr band large assembly was received for evaluation.The tr band large assembly was returned with the tr band inflator.Visual inspection revealed that the returned inflator was then used to inflate the tr band large assembly.After the balloon assembly was inflated, the assembly lost air rapidly.The assembly was then inflated and submerged underwater.A rapid trail of bubbles formed from the air inlet valve.Once the inlet valve was sealed with a thumb no other leaks were detected in the assembly.Microscopic and fluoroscopic images of the air inlet port were taken.No anomalies were observed.The valve was then deconstructed, and fiber was found on the plastic plug in the air inlet port.Terumo has determined the reported event to be manufacturing related and is being further investigated.

• Brand Name: TR BAND
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 8270763
• MDR Text Key: 133893468
• Report Number: 1118880-2019-00003
• 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: 01/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: N/A
• Device Catalogue Number: TRB29-LRG
• Device Lot Number: WE19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2019
• Date Manufacturer Received: 03/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1