MAUDE Adverse Event Report: ST. JUDE MEDICAL FOOTSWITCH PACKAGING ASSEMBLY (5M); GENERATOR, LESION, RADIOFREQUENCY

Model Number H700499

Device Problem Device Remains Activated (1525)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The results, method and conclusion codes along with investigation results will be provided in the final report.

Event Description

During a redo pvi procedure, the footswitch would start to ablate with no contact and was able stop on its own.The procedure was completed carefully with the same footswitch with no adverse patient consequences.The footswitch was replaced following the procedure.

Manufacturer Narrative

One ampere¿ footswitch was received into the lab for analysis.Visual inspection of the returned product confirmed all input and output connectors are free of physical damage and all labeling is legible and correctly oriented.The footswitch assembly was received in multiple pieces with the pedal detached from the switch and base portion.No functional testing was performed as the returned device was received in a condition which does not allow a complete investigation.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with abbott specifications and procedures.Based on the information provided to abbott and the investigation performed, the root cause of the reported event was unable to be conclusively determined.

• Brand Name: FOOTSWITCH PACKAGING ASSEMBLY (5M)
• Type of Device: GENERATOR, LESION, RADIOFREQUENCY
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 11105659
• MDR Text Key: 226067130
• Report Number: 2184149-2020-00239
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• PMA/PMN Number: P110016
• 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: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H700499
• Device Lot Number: 302467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1