MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. INQUIRY AFOCUSII¿ (4 F DOUBLE LOOP) CATHETER 20 ELECTRODE, 7F; CATHETER, ELECTRODE RECORDING

Model Number IBI-87008

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2018

Event Type  malfunction  

Event Description

During a pulmonary vein isolation procedure, the catheter was removed from the patient and the outer casing was observed to be separated.Approximately three hours into the procedure the catheter wasn't deflection normally and it was difficult to maneuver throughout the left atrium, so it was removed from the patient.Upon removal it was observed that the outer casing was separated exposing the inside of the catheter.The catheter was replaced and the procedure was completed with no adverse consequences to the patient.

Manufacturer Narrative

Additional information: device available for evaluation, date rec¿d by mfr, type of report, if follow-up, what type?, device evaluated by mfr, event problem and evaluation codes.The reported deflection issue was confirmed.The catheter deflected when actuating the steering mechanism; however, the catheter did not deflect in the correct shape according to specifications, due to the kinked spring body and fractured shaft.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the kinked spring body and fractured shaft is consistent with damage during use.

• Brand Name: INQUIRY AFOCUSII¿ (4 F DOUBLE LOOP) CATHETER 20 ELECTRODE, 7F
• Type of Device: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7277950
• MDR Text Key: 100477299
• Report Number: 2030404-2018-00012
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K042775
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/09/2018

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 Expiration Date: 03/31/2020
• Device Model Number: IBI-87008
• Device Lot Number: 5924087
• Other Device ID Number: 05414734309929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2018
• Initial Date FDA Received: 02/16/2018
• Supplement Dates Manufacturer Received: 04/21/2018
• Supplement Dates FDA Received: 05/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 56