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

Model Number N/A

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

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

Event Date 04/10/2019

Event Type  Injury  

Manufacturer Narrative

Expiration date - unknown due to lot number being unknown.Udi - unknown due to lot number being unknown.Initial reporter occupation - unknown.Implanted date: device was not implanted.Explanted date: device was not explanted.Device manufacture date - unknown due to lot number being unknown.The actual device was not returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.The product lot number was unknown, which prevented a meaningful review of the device history record and complaint files.

Event Description

The user facility reported that a terumo tr band was placed and a patient developed a small to moderate size hematoma during the transaction.The producer performed was a left heart catheterization using a terumo 6fr slender sheath.The right radial artery was accessed using a double wall technique and the sheath was introduced.The initial introduction of the sheath was smooth and uneventful.A radial cocktail was given through the sheath, (200mcg nitroglycerin, 2.5mg verapamil, 2000 units heparin) as protocol to relieve further spasms, coagulation and increase arterial dilation.A 6fr 4.5 tiger catheter was used to cannulate both the right and left coronary artery without complications.Anatomy of the right radial arterial system was normal and did not require any abnormal or further manipulation to the catheter.During the removal of the catheter, physician encountered a significant amount of resistance in the last portion of the catheter.After some struggle, the physician determined to remove the sheath and catheter as one unit.The patient was in stable condition and had further monitoring of the arteriotomy.The blood loss was reported to be less than 250cc.The procedure was completed.

Manufacturer Narrative

The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.

Event Description

Additional information was received april 26, 2019: the diagnostic "j" tip wire was used once to engage the left coronary system after the right coronary system was visualized.While the physician removed the sheath and catheter, technologist held pressure on the right radial artery and then a terumo tr band was placed with 12cc of air.The patient did develop a small to moderate size hematoma during the transaction.The patient's arm was accessed and was determined no further intervention was need.The patient was transferred to a room for port-operative observation.The estimated blood loss was 10-20cc.

Manufacturer Narrative

This report is being submitted as follow up no.2 to state that the reported event has been deemed not fda reportable based off that the tr-band reported in the event did not cause the hematoma to the patient and that it was the sheath.Therefore, see mdr 1118880-2019-00119 for the fda reportable event.

• Brand Name: UNK TR BAND
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 8556714
• MDR Text Key: 143388466
• Report Number: 1118880-2019-00099
• 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,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNK TR BAND
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2000 UNITS HEPARIN; 200MCG NITROGLYCERIN, 2.5MG VERAPAMIL; 6FR 4.5 TIGER CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 96