MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC HERO.HERO®.SUPERHERO.

Catalog Number HERO1000/A

Device Problems Break (1069); Fracture (1260)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Hypovolemia (2243); Blood Loss (2597)

Event Date 05/09/2017

Event Type  Injury  

Manufacturer Narrative

The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that the physician had a difficult time dilating the right subclavian vein and advancing the 20 french 10"peel-away sheath into the patient's right subclavian vein during access.The outflow component was prepped and advanced over the wire into the right atrium.The physician had difficulty advancing the outflow component through the sheath because the sheath was kinked.When attempting to pull back on the sheath the peel-away tabs detached from the sheath.The physician tried to remove the sheath with hemostats but was unsuccessful.The patient was hemorrhaging at this point and quickly became hemodynamically unstable.The code team was activated and blood transfusions were underway.The physician completed an emergent cut down procedure enabling him to finally remove the sheath from the subclavian vein.The vein was then sutured closed.A femoral dialysis catheter was place for patient dialysis.The patient was conscious and responding well to the physicians questions when transferring the patient to the recovery unit.

Manufacturer Narrative

The suspect device was not returned for evaluation.The complaint could not be confirmed and the root cause could not be determined.A review of the complaint database was performed and no similar complaints for this lot number were found.A review of the device history record was performed and no exception documents were found.

• Brand Name: HERO.HERO®.SUPERHERO.
• Type of Device: SUPERHERO
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: casey hughes ms, cqe, csqp ; 1600 merit parkway; south jordan, UT 84095 ; 8013164932
• MDR Report Key: 6577204
• MDR Text Key: 75503728
• Report Number: 1721504-2017-00124
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: HERO1000/A
• Device Lot Number: H1103047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2017
• 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 Outcome(s): Hospitalization; Life Threatening; Required Intervention