MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. INQUIRY¿ OPTIMA¿ DIAGNOSTIC CATHETER; CATHETER, ELECTRODE RECORDING

Model Number IBI-81659

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2018

Event Type  malfunction  

Event Description

The shaft of the catheter was noted to be separated / detached at the end of the study.There were no adverse consequences to the patient.

Manufacturer Narrative

One duodecapolar, spiral loop, inquiry optima diagnostic catheter was received for evaluation.Visual inspection revealed multiple bends on the shaft proximal to the spiral loop.Additionally, the strain relief was bent and the catheter shaft was twisted and kinked proximal to the spiral loop/shaft transition.A tear in the catheter shaft was noted 2.10¿ proximal to the spiral loop/shaft transition exposing the spring body.The catheter deflected when actuating the steering mechanism; however, did not deflect in the correct shape and did not meet specification, due to the aforementioned condition of the shaft.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Further analysis revealed the cause of the kink and tear in the shaft is consistent with damage during use.

• Brand Name: INQUIRY¿ OPTIMA¿ DIAGNOSTIC CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• MDR Report Key: 7743580
• MDR Text Key: 115834300
• Report Number: 2030404-2018-00053
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05414734305150
• UDI-Public: 05414734305150
• Combination Product (y/n): N
• PMA/PMN Number: K402775
• 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: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: IBI-81659
• Device Lot Number: 6108098
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1