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

Catalog Number XX*RF06

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Death (1802)

Event Date 01/25/2016

Event Type  Death  

Manufacturer Narrative

Udi no.- udi not yet required for this product.The actual device was not returned to the user facility for evaluation and the product code and production lot number are unknown.Therefore, the investigation was limited to evaluation of the user facility information.Since the product code and production lot number were not provided by the user facility, a meaningful review of production and complaint records could not be conducted.There is no evidence that this event was related to a device defect or malfunction.The exact cause of the complaint cannot be definitively determined.Based on the complaint description, it is likely that air was injected into the radial artery, resulting in the reported cerebral air embolism.However, it is unlikely that the involved tr-band inflator is the component that was used to inject air into the radial artery since its distal tip is designed not to be used on other devices or inserted into a conventional luer tapered port.The device labeling has the following indications by stating in the instructions-for-use (ifu): 1) do not inject air into any port other than the air injection port of this device.This could cause arterial or venous embolization.2) do not use the tr band inflator for other purposes than to inflate the tr band.It is not designed for other purposes.(b)(4).All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

Event Description

Per the attached medwatch mw5062838 received from the fda on july 12th 2016, the event description states the following: "cerebral air embolism with massive cva, likely cause: physician error.Injection of air into radial artery at time of flushing.This was prior to inflation of tr band.The tr band has a product specific syringe for inflation that cannot be used on other devices.There is a green label specifying "exclusively for air injection port." there could have been confusion on the part of the physician.The radial artery sheath has a stopcock, and will accept standard "slip tip, or "luer lock" syringes when used for aspiration/flushing.The tr band syringe with the warning label will not fit into the sheath stopcock.After the diagnosis of large cva due to air embolism, the patient was helicoptered out to ((b)(6) for treatment in the hyperbaric oxygen chamber.Air emboli were visualized in the right frontal, parietal and temporal lobes.He showed no recovery.He was transferred back to (b)(6), eventually placed on comfort care.This was radial artery sheath into which air was inadvertently injected at time of flushing.".

Event Description

The user facility reported the following additional information: it is unknown if the tr band inflator was used to inject the air or a different syringe; and it was reported that it was likely the side-port of the sheath that air was injected into.

• Brand Name: TR BAND
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: jennifer suh ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 5868029
• MDR Text Key: 51824088
• Report Number: 9681834-2016-00190
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070423
• 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: 08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XX*RF06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/18/2016
• 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
• Treatment: PSI-6F-7018
• Patient Outcome(s): Death