MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 87035

Device Problems Difficult to Remove (1528); Device-Device Incompatibility (2919)

Patient Problems Tissue Damage (2104); Device Embedded In Tissue or Plaque (3165)

Event Date 08/20/2020

Event Type  Injury  

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

It was reported that a intellamap orion high resolution mapping catheter was used in a atrial fibrillation procedure.While navigating the left atrium it was noted that the physician was unable to withdraw the orion from the patient.The physician called in a vascular surgeon for help.After trouble shooting it was decided to cut the tip off of the catheter and to leave it inside the patient.The procedure was completed with the tip remaining in the patient was kept under surveillance and on anti-coagulant.

Event Description

It was reported that a intellamap orion high resolution mapping catheter was used in a atrial fibrillation procedure.However while navigating the left atrium it was noted that the physician was unable to withdraw the orion from the patient.The physician called in a vascular surgeon for help.After trouble shooting it was decided to cut the tip off of the catheter and to leave it inside the patient.The procedure was completed with the tip remaining in the patient was kept under surveillance and on anti-coagulant.It was further reported via gfe that the catheter was disposed.Literature article was received.It was further reported that a patient with ischemic cardiomyopathy and severe left ventricular dysfunction was referred for catheter ablation of a symptomatic atypical atrial flutter.Preprocedural computed tomography was performed to appreciate atrial anatomy, and rule-out intra-atrial thrombus.Catheter ablation was performed under mild sedation, uninterrupted direct oral anticoagulant and three right femoral venous sheaths.A decapolar diagnostic catheter was positioned in the coronary sinus, with a distal coronary sinus primo-activation pattern.Left atrium (la) activation mapping was performed using a sensor-based 64-electrode basket catheter (intellamap oriontm, boston scientific, usa) through a trans-septal puncture in combination with a long sheath.Activation mapping found a septal anterior primo-depolarization.The la sheath was left in place and right atrial activation mapping was attempted by introducing the basket catheter in a short 8.5fr sheath.During initial progression from the right femoral vein, the basket catheter was trapped at the ostium of the right internal iliac vein.Ipsilateral upward or downward traction/rotation were performed using an non-boston scientific endovascular snare system, unsuccessfully.Considering a possible transfixing tip of the catheter and the patient's pain, a multidisciplinary decision of surgical extraction was considered.Atrial overdrive was performed, followed by the removal of all catheters and sheaths.The basket catheter was cut-off to the skin and the tip of the catheter was left abandoned.Surgical removal was performed 24 hours later by hemisection of the common femoral vein through a direct anterior approach.After thrombectomy, the catheter tip was extracted using a non-boston scientific ring dissector, with a remnant of an iliac valve found between 2 splines of the basket catheter.Patient was discharged 24 hours after surgery.At 3-months, vascular ultrasound found an asymptomatic refluxing proximal segment of the right internal iliac vein during valsalva manoeuvre, and no evidence of deep venous thrombosis.Ollitrault, p., champ-rigot, l., ferchaud, v., pellissier, a., coffin, o., & milliez, p.(2020).Vascular entrapment of a multipolar basket catheter (orion) during catheter ablation.Journal of cardiovascular electrophysiology.Doi:10.1111/jce.14780.

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

• Brand Name: INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10489618
• MDR Text Key: 205539822
• Report Number: 2134265-2020-12282
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729841968
• UDI-Public: 08714729841968
• Combination Product (y/n): N
• PMA/PMN Number: K143481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/21/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 87035
• Device Catalogue Number: 87035
• Device Lot Number: 0024354629
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/20/2020
• Initial Date FDA Received: 09/03/2020
• Supplement Dates Manufacturer Received: 10/20/2020
• Supplement Dates FDA Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR