MAUDE Adverse Event Report: ST. JUDE MEDICAL VIEWFLEX¿ XTRA ICE CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number D087031

Device Problems Fracture (1260); Material Separation (1562); Activation, Positioning or Separation Problem (2906)

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

Event Date 04/04/2022

Event Type  malfunction  

Event Description

During an atrial fibrillation ablation procedure, steering issues were noted while forcefully inserting the catheter.Noticing the steering was abnormal when pulling out catheter, the physician decided to proceed anyway.Under fluoroscopy the tip of the catheter was noted to be floppy and appeared partially disconnected.Another catheter was used to complete the procedure with no consequences to the patient.

Event Description

Fda ref: (b)(4).

Manufacturer Narrative

One viewflex xtra ice catheter was received for evaluation.The catheter shaft deflected in both directions when actuating the anterior/posterior (a/p) knob.The catheter shaft also deflected in both directions when actuating the left/right (l/r) knob.The reported deflection issue could not be confirmed, however the catheter tip was noted to be fractured.The catheter deflected in all directions and met specifications for curve shape when actuating the steering mechanisms.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the deflection issue remains unknown.

• Brand Name: VIEWFLEX¿ XTRA ICE CATHETER
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 14112720
• MDR Text Key: 289276942
• Report Number: 3008452825-2022-00378
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 05415067002082
• UDI-Public: 05415067002082
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133853
• 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: 05/20/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: D087031
• Device Catalogue Number: D087031
• Device Lot Number: 8237910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/04/2022
• Initial Date FDA Received: 04/14/2022
• Supplement Dates Manufacturer Received: 05/12/2022
• Supplement Dates FDA Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: 51 YR