MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE VELOCITY¿ FIBER OPTIC CABLE DUPLEX LC/LC 15M; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number 100044301

Device Problem Mechanical Problem (1384)

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

Event Date 08/15/2022

Event Type  malfunction  

Event Description

During the supraventricular tachycardia procedure, the cable was damaged accidentally which caused a delay in the procedure.The issue was resolved by borrowing a cable from another hospital.The procedure was successfully completed with no adverse consequences to the patient.

Event Description

During the supraventricular tachycardia procedure, the cable was damaged accidentally when it was caught on a person's foot, which caused a delay in the procedure.The issue was resolved by borrowing a cable from another hospital.The procedure was successfully completed with no adverse consequences to the patient.

Manufacturer Narrative

Per the reporting person, the cable was damaged on accident when it was caught on a person's foot.Due to the issue being the result of accidental damage this event is not reportable.

• Brand Name: ENSITE VELOCITY¿ FIBER OPTIC CABLE DUPLEX LC/LC 15M
• 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: 15322377
• MDR Text Key: 304373933
• Report Number: 2184149-2022-00196
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 09/26/2022

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: 100044301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/24/2022
• Initial Date FDA Received: 08/30/2022
• Supplement Dates Manufacturer Received: 09/12/2022
• Supplement Dates FDA Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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