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

Model Number N/A

Device Problem Deflation Problem (1149)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/12/2020

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: 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 device was placed in lab.The patient was moved across the hall to recovery when the band was discovered to be deflated.A new band was placed, and the patient was monitored during recovery.There was no hematoma or additional complications noted.The patient was in good condition.The procedure outcome was successful.There was no patient injury, medical/surgical intervention required.

Manufacturer Narrative

This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.One large tr band assembly was returned to terumo medical corporation for product evaluation.The returned components were subjected to visual inspection and no anomalies were noted.The return device was inflated with 15 ml of air and submerged in water.Air bubbles were noted at the communication port between the large and small balloons.The communication port was visually inspected, and it was noted that the communication port was partially ripped apart.The complaint can be confirmed for airflow issues.It is likely that the balloons were attempted to be separated prior to inflating which could have caused the rip in the communication port therefore resulting in the air leakage.The device was in a conforming state when released from terumo control.There is no indication that any manufacturing, design or quality system issues may have led to this event.Currently, no action is recommended since this risk evaluation is within the predetermined limits in the failure mode and effects analysis (fmea).

• Brand Name: TR BAND
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 11050895
• MDR Text Key: 223358686
• Report Number: 1118880-2020-00332
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: N/A
• Device Catalogue Number: TRB29-LRG
• Device Lot Number: XN19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Date Manufacturer Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR