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

Model Number N/A

Device Problem Inflation Problem (1310)

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

Event Date 09/23/2020

Event Type  malfunction  

Manufacturer Narrative

Expiration date: unknown due to unknown lot number.Udi unknown due to unknown lot number; implanted date: device was not implanted; explanted date: device was not explanted; device manufacturer date - unknown due to unknown 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

The user facility reported that tr band would not stay inflated.It was reported that they thought the leak was in balloon.The patient was unaffected.The producer outcome was unaffected.There was no patient injury, medical/surgical intervention required.Additional information was received on 12november2020: procedure was left heart catheterization (lch) radial.A second tr-band was used when difficulty occurred.There was no patient injury including hematoma, or excessive blood loss greater than 250cc.The patient condition was stable.

Manufacturer Narrative

This report is being submitted as follow up no.2 to provide the nonconformance investigation.Per the nonconformance investigation, the probability of valve contamination with foreign material during the manufacturing process is low.The preventive measures listed provide process robustness in minimizing foreign material contamination in manufacturing.Since the foreign material could not be analyzed, it is not possible to determine the material composition, the likelihood of material origin, or possible foreign material ingress source into the device.

Manufacturer Narrative

This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.One used regular tr band assembly was returned to terumo medical corporation for product evaluation.The returned device was subjected to visual inspection and no anomalies were noted.The sample was subjected to leak testing.The inflator was used to inflate the tr band with 18 ml of air.The inflated tr band was then submerged underwater and air bubbles were seen at the air inlet valve.No bubbles were observed along with the seals of the large and small balloons.The valve was then deconstructed and examined under the microscope.Foreign matter was found on the air inlet valve.During the investigation, the sample was compromised and could not be fourier-transform infrared spectroscopy (ftir) tested.The operations quality engineer was informed about this complaint and nonconformance was issued to further investigate this issue.Based on the returned device, the complaint can be confirmed for airflow issues since air bubbles were observed during leak testing at the air inlet valve.It is likely the foreign matter observed did not allow the air inlet valve to properly close therefore causing air to leak out.Nonconformance was initiated and completed.

• Brand Name: TR BAND
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 10896142
• MDR Text Key: 221009607
• Report Number: 1118880-2020-00301
• 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,Followup
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• 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: 11/16/2020
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1