MAUDE Adverse Event Report: CRYOLIFE, INC. CRYOPATCH® SG PULMONARY HUMAN CARDIAC BRANCH PATCH; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Model Number SGP020

Device Problems Fungus in Device Environment (2316); Patient-Device Incompatibility (2682)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/04/2010

Event Type  malfunction  

Event Description

The surgeon requested a homograft to be thawed for use in the procedure for patient.The homograft was properly thawed and prepared per manufacturing directions.Homograft routinely cultured prior to implantation and culture came back positive for aspergillus.Blood cultures also came back negative.The patient was given voriconozale, and antifungal, postoperatively for 48 hours until cultures came back negative.Health professional's impression.It is difficult to confirm or rule out fungal infection in the homograft, a single negative galactomannin antigen result does not rule out invasive disease.Because at this point is very difficult to exclude a real infection and the consequences of not treating can be fatal; we will continue to treat with antifungals.Manufacturer response for homograft, pulmonary branch patch.This incident was reported to sales representatives.Cryolife responded and stated a thorough investigation will be done.A questionnaire was filled out by our staff at our facility and faxed back to cryolife.They are working on the investigation.

• Brand Name: CRYOPATCH® SG PULMONARY HUMAN CARDIAC BRANCH PATCH
• Type of Device: PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd nw; kennesaw GA 30144
• MDR Report Key: 16663271
• MDR Text Key: 312529832
• Report Number: 16663271
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/18/2010,03/17/2010

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SGP020
• Device Catalogue Number: SGP020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/18/2010
• Event Location: Hospital
• Date Report to Manufacturer: 04/03/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 150 DA
• Patient Sex: Male
• Patient Weight: 6 KG
• Patient Ethnicity: Hispanic