MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. AO USB RECEIVER; TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY

Model Number C12782

Device Problem Communication or Transmission Problem (2896)

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

Event Date 12/04/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Related manufacturing ref: 2184149-2020-00241, 3009600098-2020-00029.During the procedure, a significant delay occurred.The start up of the system was significantly prolonged and "ffr receiver fault detect" was displayed after startup.The connection between the catheter and the doc failed and it took two to three times to connect successfully.After detection the imaging effect was not good, the brightness and contrast were not high, and the nature of the plaque could not be seen clearly.The procedure was completed with the same system with no adverse patient consequences.The ffr receivers and optical adapter were replaced to resolve the issue.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received and electronic data, the reported incident is verified to have occurred, but the cause could not be determined.

• Brand Name: AO USB RECEIVER
• Type of Device: TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 11095652
• MDR Text Key: 224387529
• Report Number: 2184149-2020-00240
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• PMA/PMN Number: K111854
• 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: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: C12782
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ILUMIEN OPTIS SYSTEM; PW USB RECEIVER; ILUMIEN OPTIS SYSTEM; PW USB RECEIVER
• Patient Outcome(s): Other