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

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

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

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

The following was published in the journal of cardiovascular electrophysiology in an article titled ¿entrapment of diagnostic catheter within advisor hd grid mapping catheter¿ by mar p, chong l, perez a, et al., 21 january 2021.¿the entrapment of circular mapping catheters has previously been described before, but no reports of entrapment between the advisor hd grid and other catheters have been published.A (b)(6) year-old female presented with recurrent, symptomatic, medically refractory supraventricular tachycardia (svt) and underwent electrophysiology study (eps).The diagnostic study used two quadripolar 6 french (fr) diagnostic catheters, one placed in the high right atrium (hra, inserted from left femoral vein) and the other in the right ventricular apex (inserted from right femoral vein), a decapolar coronary sinus catheter, a deflectable quadripolar catheter in the his bundle location.These were placed through short sheaths in both right and left femoral vein.Svt was then induced and was diagnosed to be a right atrial tachycardia, and a high-definition, multi-electrode mapping catheter - advisor hd¿ grid was used for activation mapping of the right atrium.This was placed through an 8f sheath in the right femoral vein after removing the his bundle catheter.An automatic focus was successfully mapped to the low posterior septal right atrium, but upon withdrawal of the hd grid multielectrode catheter to exchange for an ablation catheter, considerable resistance was encountered.Fluoroscopy revealed that quadripolar diagnostic catheter positioned in the hra had become inextricably entangled within the struts of the hd grid.Despite several minutes of careful manipulation of both catheters to free them from each other, the tips of both catheters were withdrawn snugly into the 8fr short sheath in the right femoral vein.Since both these catheters were stuck inside the 8f sheath, the sheath was pulled back outside the body along with the entire hd grid catheter and just the tip of the hra diagnostic catheter (which had been inserted from the left femoral vein).The sheath was slit and using surgical shears, the struts of the hd grid were cut to free the quadripolar diagnostic catheter from the hd grid.Proximal to the point of entanglement, the structural integrity of the quadripolar catheter appeared grossly intact, and another 8fr sheath was advanced over the quadripolar catheter using it as a "guidewire" back into the right femoral vein so that the access site was retained.Following this, an ablation catheter was inserted into this newly placed 8fr sheath, and the focal source of the atrial tachycardia was eliminated by ablation.After the procedure, all catheters/sheaths were withdrawn, and a figure-of-8 suture was placed at each femoral site for hemostasis.A femoral ultrasound performed the day after the procedure demonstrated no vascular complication.¿ (doi: 10.1111/ jce.14893).

• 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: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 11265355
• MDR Text Key: 229812939
• Report Number: 3005334138-2021-00058
• 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: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/25/2021
• Initial Date FDA Received: 02/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 61 YR