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

Catalog Number TRB29-LRG

Device Problem Use of Device Problem (1670)

Patient Problems Hematoma (1884); Blood Loss (2597)

Event Date 03/27/2017

Event Type  Injury  

Manufacturer Narrative

The actual device was not returned to the manufacturing facility for evaluation.Therefore, the investigation is based on the user facility information and evaluation of a retention sample of the reported product code/lot number combination and surrounding lots.Visual inspection revealed no defects.A review of the device history record of the product code/lot# combination was conducted with no relevant findings.The same user facility reported another event with a similar device.See mdr 1118880-2017-00031.The investigation results verified that the retention sample was the normal product.The exact cause of the reported event cannot be definitively determined and there is no evidence that this event was related to a device defect or malfunction.Based on the investigation results and the information provided by user facility, the reported issue may be contributed to user error.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow up.Device not available.

Event Description

The user facility reported the patient bled significantly after the tr band device was applied during the recovery period.Follow up communication with the user facility on april 5, 2017 reported the following information: the tr band was placed post procedure in the procedure room; the device appeared to achieve hemostasis initially; the patient was in the recovery area and during check of the site a large hematoma with significant swelling was present; manual compression was applied for approximately 20 minutes; a pressure dressing was applied to the arm; it was reported that the issue appeared to be that "the inflation balloon that puts direct pressure on the artery seems to be directed medially" and may have put pressure on the radial artery initially but then "turns", and since it is no longer applying direct pressure bleeding and hematoma occurs"; it was reported that the issue is not with the band losing air, but something to do with the positioning of the balloon; blood loss was reported to be approximately 15ml; it was reported ecchymosis on the patient's arm; and the patient was discharged home.Additional information was received 3/31/2017: the patient is ok and they were able to stop the bleeding.The customer has years of experience with tr band, but only recently started having problems with bleeds.The bleed occurred while the band was still in place while the patient was in recovery.

• Brand Name: TR BAND
• Type of Device: VASCULAR CLAMP
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer Contact: jennifer suh ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6520763
• MDR Text Key: 73665732
• Report Number: 1118880-2017-00032
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00389701011356
• UDI-Public: (01)00389701011356(17)190531(10)UP19
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: TRB29-LRG
• Device Lot Number: UP19
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/28/2017
• Initial Date FDA Received: 04/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GLIDESHEATH SLENDER SHEATH
• Patient Outcome(s): Required Intervention