MAUDE Adverse Event Report: HEMOSPHERE, INC. HERO GRAFT; VASCULAR GRAFT

Model Number HERO 1003

Device Problems Arcing (2583); Material Integrity Problem (2978)

Patient Problem Injury (2348)

Event Date 04/24/2014

Event Type  Injury  

Event Description

According to the report, during the surgeons first case, he indicated he was disappointed with the sheaths and dilators (the accessory kit in general).He had difficulty using the sheaths and called them "archaic" and cheap.The surgeon asked why cryolife still used such outdated items.The sheath caused damage to the inner lumen of the jugular vein entering the superior vena cava.He used the included dilators as well as a terumo "destination" sheath and an 8f x 4cm balloon to gain access to the right atrium.

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Manufacturer Narrative

"date of this report", corrected to 04/29/2014."date received by manufacturer", corrected to 04/29/2014.Manufacturer narrative: according to the report, during the surgeons first case he indicated he was disappointed with the sheaths and dilators (the accessory kit in general).He had difficulty using the sheaths and called them "archaic" and cheap.The surgeon asked why cryolife still used such outdated items.The sheath caused damage to the inner lumen of the jugular vein entering the superior vena cava.He used the included dilators as well as a terumo "destination" sheath and an 8f x 4cm balloon to gain access to the right atrium.The manufacturing records for lot h13ak016 were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.The hero graft instructions for use (ifu) lists trauma to major vasculature as a potential complication and gives directions as to proper use of the sheath, "insert the short 20f introducer from the accessory component kit of the guidewire.The long 20f introducer may be used if need for atypical accesses.Note: use of the shorter introducer may help prevent kinking since it cannot be advanced as far into the vessel." a review of the manufacturing records has been performed.There is no indication that an error or deficiency occurred at cryolife.

Event Description

According to the report, during the surgeons first case he indicated he was disappointed with the sheaths and dilators (the accessory kit in general).He had difficulty using the sheaths and called them "archaic" and cheap.The surgeon asked why cryolife still used such outdated items.The sheath caused damage to the inner lumen of the jugular vein entering the superior vena cava.He used the included dilators as well as a terumo "destination" sheath and an 8f x 4cm balloon to gain access to the right atrium.

• Brand Name: HERO GRAFT
• Type of Device: VASCULAR GRAFT
• Manufacturer (Section D): HEMOSPHERE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer (Section G): HEMOSPHERE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer Contact: sandra o'reilly ; 1655 roberts blvd., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 3830060
• MDR Text Key: 18734603
• Report Number: 3006945290-2014-00040
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: HERO 1003
• Device Lot Number: H13AK016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2014
• 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 Outcome(s): Other