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

Catalog Number TRB24-REG

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Date 06/02/2017

Event Type  malfunction  

Manufacturer Narrative

Age at time of event - it was reported that the patient was (b)(6) years old.Udi no.- unknown as the involved lot number is unknown.The actual device was not returned to the manufacturing facility for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.For this reason, evaluation code 20 has been referenced in the conclusions section of h6.The production lot number was not provided by the user facility, which prevented a meaningful review of production records.A search of the complaint file did found ten similar reports with the involved product family within the past year.Three year trending for this product family could not be conducted as this product was launched in 2016.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.Device not returned to manufacturer.

Event Description

The user facility reported they patient had hematoma after tr band placement.The following information was provided by the user facility: (1) patient had hematoma in post recovery; (2) patient was reported to be ok; and (3) the procedure was successful.Additional information was received on june 13, 2017.The procedure that was performed which resulted in hematoma was a heart catheterization procedure.No treatment was required for hematoma, and the location of the hematoma was right radial.Additional information was received on june 14, 2017.There was no reported blood loss.Additional information was received on june 15, 2017.The tr-band was used as intended.

Manufacturer Narrative

The report is being submitted as follow-up no.1 to provide the completed investigation results.No evaluation could be conducted due to the device not being returned.There is no evidence that this event was related to a device defect or malfunction.Without the return of the actual device the exact cause of the reported event cannot be definitively determined.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

• 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: terry callahan ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6667469
• MDR Text Key: 78500700
• Report Number: 1118880-2017-00044
• Device Sequence Number: 1
• Product Code: DXC
• 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,Followup
• Report Date: 06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TRB24-REG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 70 YR