MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE X EP SYSTEM FIELD FRAME CABLE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number ENSITE-FF-4.5C-01

Device Problem Material Twisted/Bent (2981)

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

Event Date 11/17/2022

Event Type  malfunction  

Event Description

During an atrial flutter procedure, there was a bent pin on the field frame cable, causing a clinically significant delay.The magnet was placed successfully at the beginning of the case, removed for a heart cath, then replaced.When the magnet was replaced it was noted that patches could not be visualized despite field frame repositioning.The connections were tested and it was noted that the field frame cable had a bent pin.The procedure was completed in navx mode without patient complications.

Event Description

Correct model number: (b)(4).

Manufacturer Narrative

Corrected information: b5, d4, g3, h2 the correct model number of the complaint device is: (b)(4).

Manufacturer Narrative

Visual inspection of the returned field frame cable revealed a bent pin in the connector, consistent with the reported connection issue.Based on the information provided to abbott and the investigation performed, the root cause of the reported event was confirmed and was isolated to the bent pin.Review of the device history record was not possible as the lot number is unknown.

• Brand Name: ENSITE X EP SYSTEM FIELD FRAME CABLE
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15865028
• MDR Text Key: 304894810
• Report Number: 2184149-2022-00281
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENSITE-FF-4.5C-01
• Device Catalogue Number: ENSITE-FF-3MC-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2022
• Initial Date FDA Received: 11/25/2022
• Supplement Dates Manufacturer Received: 12/08/2022; 12/08/2022
• Supplement Dates FDA Received: 12/08/2022; 12/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1