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

Model Number N/A

Device Problem Inflation Problem (1310)

Patient Problem Blood Loss (2597)

Event Date 05/03/2019

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 the tr band would not maintain inflation upon initial use.Deflation occurred within seconds.A second tr band was applied with no issues.The procedure was completed successfully and the patient was reported to be in stable condition.The patient proceeded to recovery with no further delays.There was a 10cc blood loss upon sheath removal.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the device return date in the d10 section, and to update the h3 section.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.2 to provide the additional information in the b5 section completed investigation results.One used regular tr band assembly was returned for product evaluation.The inflator was not returned for product evaluation.Microscopic images of the air inlet port were taken.No anomalies were observed at the inlet port.It was noted that the communication port which attaches the small balloon and the large balloon is ripped.Leak testing was not able to be performed due to the communication port being torn.Based on the provided information and investigation results there is no evidence that this event was related to a device defect or malfunction.Based on the investigation results, it is likely that the balloons separated which caused the reported event.However, the exact cause of the reported event cannot be definitely determined based on the available information.

Event Description

Additional information was received 28august2019: the procedure performed was a coronary angiogram.

Event Description

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

Manufacturer Narrative

This report is being submitted as follow up no.3 to provide additional information to the g3 and b5 section.

• Brand Name: TR BAND
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 8771309
• MDR Text Key: 150456831
• Report Number: 1118880-2019-00165
• 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

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Initial Date Manufacturer Received: 06/19/2019
• Initial Date FDA Received: 07/09/2019
• Supplement Dates Manufacturer Received: 07/23/2019; 09/04/2019; 08/13/2019
• Supplement Dates FDA Received: 08/09/2019; 09/04/2019; 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1