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

Model Number HERO 1002

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/21/2014

Event Type  malfunction  

Event Description

According to the report, the surgeon stated to the cryolife representative that he used a vascular clamp just lateral to the connector on the hero 1002 (arterial graft component).While clamping the 1002, he stated that the graft portion of the hero 1002 tore rendering the hero 1002 unusable.He replaced the hero 1002 with a new hero 1002 with no complications.

Manufacturer Narrative

Sample was returned and reviewed on (b)(4) 2014.During the sample review, it was noted that the graft was cut at the connector.The cut was flush with the edge of the connector; however, there were no obvious markings caused by the use of a clamp in the area near the cut.Markings indicative of a clamp were present at the distal end of the graft.This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Manufacturer Narrative

The surgeon stated that he used a vascular clamp just lateral to the connector on the hero 1002 (arterial graft component (acg)).While clamping the acg, he stated that the graft portion of the connector tore rendering the acg unusable.He replaced the acg with a new acg with no complications to the patient.Additional information regarding the use of the clamp was requested.Multiple attempts have been made to obtain this additional information from the surgeon, but no additional information was provided.A sample was returned for evaluation.The sample was returned in a biohazard bag and surgical drape but was transferred to 10% formalin upon receipt on 4/23/2014.The sample was removed for 10% buffered formalin and evaluated in a biological safety cabinet on (b)(6) 2014.During sample review, it was noted that graft was cut flesh with the edge of the connector.There were no obvious markings caused by the use of a clamp in the area near the cut.However, markings indicative of a clamp were present at the distal end of the graft.Damage was most likely caused by user error.The graft was severed cleanly near the connector.While no obvious clamp marks were visible on the sample, the surgeon stated a clamp was used in this area.It is possible the damage to the graft was caused by the clamp.The hero graft instructions for use states "do not grasp, peel, or otherwise damage the acg beads as this may adversely impact the integrity of the graft." the manufacturing records for lot h14av001 were reviewed by and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.The damage to the graft was most likely caused by user error.The graft was severed cleanly near the connector.While no obvious clamp marks were visible on the sample, the surgeon stated a clamp was used in this area.It is possible the damage to the graft was caused by the clamp.The ifu states "do not grasp, peel, or otherwise damage the acg beads as this may adversely impact the integrity of the graft.It is important during device connection to grasp the silicone sleeve of the agc and avoid contact with the beading.Ensure beading is not crushed or damaged.If damage to the beading is noted during implant, a new arterial graft component should be used." the ifu also cautions "use only the disposable clamp included in the accessory component kit.Use of other clamps may result in damage to the device.Be careful not to over clamp the disposable clamp.Note: avoid beaded region of the arterial graft component.".

Event Description

According to the report, the surgeon stated to the cryolife representative that he used a vascular clamp just lateral to the connector on the hero 1002 (arterial graft component).While clamping the 1002, he stated that the graft portion of the hero 1002 tore rendering the hero 1002 unusable.He replaced the hero 1002 with a new hero 1002 with no complications.

• 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: 3815335
• MDR Text Key: 17574173
• Report Number: 3006945290-2014-00039
• 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: 04/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: HERO 1002
• Device Lot Number: H14AV001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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