MAUDE Adverse Event Report: ST. JUDE MEDICAL ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number D-AVHD-DF16

Device Problems Entrapment of Device (1212); Material Frayed (1262); Material Separation (1562)

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

Event Date 01/19/2022

Event Type  malfunction  

Event Description

During a right atrial flutter procedure, an entanglement of the catheters occurred.Initially the mapping catheter was inserted via a right femoral venous sheath and a diagnostic catheter was introduced into a left femoral venous sheath.While maneuvering the diagnostic catheter, it became entangled in the splines of the mapping catheter.The issue was not immediately apparent to the physicians, so when attempting to remove the mapping catheter to replace it with the ablation catheter, both the mapping catheter and diagnostic catheter began to start pulling into the right venous sheath.Both of the catheters then became stuck in the sheath.Attempts were made to advance the mapping catheter out of the sheath, however, the issue remained.It was then decided to remove the venous access sheath altogether containing the entangled catheters.A wire was advanced into the vein to maintain access and the sheath was gently retracted from the patient, which allowed the catheters to be untangled and removed.The diagnostic catheter was then advanced back into the patient with a gentle countertraction applied and was ultimately able to be completely removed.The mapping catheter appeared to have been stretched, frayed, and a portion of the tip was detached.It was confirmed that no components of the mapping catheter remained in the patient.The physicians then re-established venous access and completed the procedure successfully.There were no adverse consequences to the patient.

Manufacturer Narrative

One bi-directional, curve d-f, sensor enabled, advisor hd grid mapping catheter was received for evaluation.The electrodes were displaced and the pellethane tubing and splines were corrugated and torn.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the entanglement, torn pellethane tubing, and displaced electrodes remains unknown.

• Brand Name: ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13558519
• MDR Text Key: 286648786
• Report Number: 3005334138-2022-00035
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172393
• 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: 04/25/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: D-AVHD-DF16
• 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: 01/19/2022
• Initial Date FDA Received: 02/18/2022
• Supplement Dates Manufacturer Received: 04/01/2022
• Supplement Dates FDA Received: 04/25/2022
• 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: 49 YR
• Patient Sex: Female