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 Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2018

Event Type  malfunction  

Manufacturer Narrative

One inquiry afocusii diagnostic catheter was received for evaluation.Visual inspection revealed a kink in the shaft noted 1.25¿ proximal to the sprial loop/shaft transition.Bends throughout the catheter shaft were noted proximal to the spiral loop/shaft transition.The catheter shaft had been twisted, had torn between 2.15¿ and 2.35¿ proximal to the spiral loop/shaft transition, exposing the internal spring body tube.The cause of the fractured and splitting the blue shaft was due to the catheter being over torqued during use.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.

Event Description

During procedure, the surface material of the catheter was torn.The catheter was replaced and the procedure was completed with no adverse consequences to the patient.

• 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: 7457422
• MDR Text Key: 107085805
• Report Number: 2030404-2018-00031
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 04/25/2018

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: 07/31/2020
• Device Model Number: IBI-87008
• Device Lot Number: 6102105
• Other Device ID Number: 05414734309929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2018
• Initial Date FDA Received: 04/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2017
• 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