MAUDE Adverse Event Report: CRYOLIFE, INC. CRYOPATCH SG PULMONARYTRUNK; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Model Number SGP010

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

Patient Problem Insufficient Information (4580)

Event Date 04/07/2022

Event Type  Injury  

Event Description

According to the initial report, sgp010, sid (b)(6) was implanted on (b)(6) 2022 and explanted on (b)(6) 2022.

Event Description

According to the initial report, (b)(4), sid (b)(6) was implanted on (b)(6) 2022 and explanted on (b)(6) 2022.

• Brand Name: CRYOPATCH SG PULMONARYTRUNK
• Type of Device: PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer (Section G): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 14519657
• MDR Text Key: 294784879
• Report Number: 1063481-2022-00007
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101866
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: SGP010
• Device Catalogue Number: SGP010
• Device Lot Number: 163714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/26/2022
• Initial Date Manufacturer Received: 04/26/2022
• Initial Date FDA Received: 05/26/2022
• Supplement Dates Manufacturer Received: 04/26/2022
• Supplement Dates FDA Received: 07/31/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Age: 3 YR
• Patient Sex: Female