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

Model Number N/A

Device Problems Inflation Problem (1310); Gas/Air Leak (2946)

Patient Problem Blood Loss (2597)

Event Date 08/12/2019

Event Type  malfunction  

Manufacturer Narrative

Date of birth - patient born in (b)(6).Expiration date - unknown due to unknown catalog and lot number.Udi - unknown due to unknown catalog and lot number.Implanted date: device was not implanted.Explanted date: device was not explanted.Manufacture date - unknown due to unknown catalog and lot number.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.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record.

Event Description

Terumo medical received an fda medwatch report # (b)(4).The event description states: "2 ml air was withdrawn from the tr band twice while gradually deflating over time.After second withdrawal of air, one-way valve apparently leaked and with one minute of second withdrawal all of the air had leaked out and the patient started bleeding at puncture site.Fortunately, when reflated, valve held air.Device sequestered however packaging was not saved." additional information was received 07january2019: the procedure performed was a left heart catheterization with coronary arteriogram.There was minimal blood loss.There was no noticeable damage to the device that the staff could see.The patient was stable.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide an update to the h3 section and to provide the completed investigation results.One used tr band assembly and its inflator was returned for product evaluation.Visual inspection revealed that the and no damage or gross anomalies were observed.Leak testing was performed the tr band inflator was used to inflate the tr band with 15 ml of air.The inflated tr band stayed inflated for 24 hours.The inflator was connected to the inflation balloon and retracted past the 20 ml graduation mark and released.The plunger settled at the 13 ml graduation mark.The tr band passed leak testing because 13 ml of air remained in the tr band.The tr band was inflated with 18 ml of air and submerged in water.No air bubbles were observed along with the seals of the large and small balloons and no air bubbles were seen at the inflation balloon.Based on the provided information and investigation results there is no evidence that this event was related to a device defect or malfunction.The investigation results verified that the returned device was the normal product.However, the exact cause of the reported event cannot be 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: 9653052
• MDR Text Key: 200611420
• Report Number: 1118880-2020-00002
• Device Sequence Number: 1
• Product Code: DXC
• 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: 01/31/2020

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Initial Date Manufacturer Received: 01/03/2020
• Initial Date FDA Received: 01/31/2020
• Supplement Dates Manufacturer Received: 02/26/2020
• Supplement Dates FDA Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 53