MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. SUPERHERO GRAFT ADAPTER

Catalog Number HERO1000/A

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

Patient Problems Perforation of Vessels (2135); Sudden Cardiac Death (2510)

Event Date 05/06/2019

Event Type  Death  

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 reported that a physician was teaching another physician how to implant the hero graft.The patient's left jugular vein was punctured as normal.The guidewire was advanced and continued along the brachiocephalic vein to the superior vena cava [svc], through the right atrium and into the inferior vena cava [ivc] as intended.The access site was then dilated with the appropriate dilators and the trainee noted that when he inserted the short 20f splittable sheath included with the super hero he was not confident about the position.He stated that it should have moved slightly to the right to follow the guidewire but instead went straight down.The available fluoroscopy images confirmed the sheath dilator perforated the inferior wall of the brachiocephalic vein.Following this discovery, the physician withdrew the guidewire and the sheath.The trainee recalled a tactile "pop" as the wire and sheath were retracted.Fluoroscopy images showed a visibly damaged guidewire and dilator.It was discovered at this point that the patient was now bleeding internally and a chest drain was inserted successfully.Shortly thereafter the patient went into cardiac arrest and cpr was performed unsuccessfully.The patient expired.

Manufacturer Narrative

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

• Brand Name: SUPERHERO GRAFT ADAPTER
• Type of Device: GRAFT ADAPTER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 w merit parkway; south jordan 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 1600 w merit parkway; south jordan 84095
• Manufacturer Contact: katie swenson, cqe, cba, cqpa ; 1600 w merit parkway; south jordan 84095 ; 8012081600
• MDR Report Key: 8831570
• MDR Text Key: 152352020
• Report Number: 1721504-2019-00063
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K124039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: HERO1000/A
• Device Lot Number: H1255287
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2018
• 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: 8F SHEATH
• Patient Outcome(s): Death; Life Threatening
• Patient Age: 65 YR