MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. SJM PERICARDIAL PATCH WITH ENCAP AC TECHNOLOGY; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Model Number C0405

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/19/2019

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2019, a 4/5cm pericardial path with encap ac technology.During the procedure, while the heart was clamped and circulating extracorporeally, the pericardial patch was noted to have a black deposit.The product was still sealed.The light and temperature were correct.This caused a delay in the procedure.

Manufacturer Narrative

Correction: g1.Additional information revealed the initial mdr for this event was reported under the incorrect mfr report number 3007113487 and manufacturing site.Corrected manufacturing site information has been provided in g1.The correct mfr number is (b)(4).The reported event of a pericardial patch with a black deposit was confirmed.The investigation found that the patch had fungal overgrowth on the tissue surfaces, which was interpreted as a contaminate by pathology.The tamper evident seal of the returned patch was partially torn, indicating that the patch had been opened, which compromised its sterility.It could not be conclusively determined how or when this damage occurred.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization, including passing sterility testing.The sterility of the patch is guaranteed prior to it being opened.The cause of the reported event could not be conclusively determined.

• Brand Name: SJM PERICARDIAL PATCH WITH ENCAP AC TECHNOLOGY
• Type of Device: PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• MDR Report Key: 8937491
• MDR Text Key: 155780983
• Report Number: 3007113487-2019-00023
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• PMA/PMN Number: K963967
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2021
• Device Model Number: C0405
• Device Catalogue Number: C0405
• Device Lot Number: T1810303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization