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); Activation, Positioning or Separation Problem (2906)

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

Event Date 01/17/2024

Event Type  malfunction  

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported that an intellamap orion catheter during ablation on a patient with a complex vascular access, presented a deployment undeployment failure, and was damaged at the moment of insertion.The patient was overweighted, and the physician had very difficult access to the right atrium through the femoral vein.On the way up, the orion got stuck and this meant that the orion could not be used.The array was unable to undeploy, so the catheter was removed with difficulties due to patient's anatomy.The orion mechanism was bent and the opening and closing of the orion stopped working.The catheter was removed from the patient's body and replaced with another one of the same type.The procedure then was completed without patient complications.The device is expected to be returned.

Manufacturer Narrative

Analysis of returned product revealed that the device has a kink in the catheter shaft, consequently confirming the reported catheter "difficult to withdraw" event.The catheter deployment/undeployment failure is not confirming the reported event since deployment slider functioned properly, and the basket shape was formed.No abnormal resistance was felt when executing the steering mechanism and deployment system.

Event Description

It was reported that an intellamap orion catheter during ablation on a patient with a complex vascular access, presented a deployment/undeployment failure, and was damaged at the moment of insertion.The catheter was removed from the patient's body and replaced with another one of the same type.The procedure then was completed without patient complications.The device is expected to be returned.It was further reported that no pictures were available.The patient was overweighted, and the physician had very difficult access to the right atrium through the femoral vein.On the way up, the orion got stuck and this meant that the orion could not be used.The array was unable to undeployed, so the catheter was removed with difficulties due to patient's anatomy.The orion mechanism was bent and the opening and closing of the orion stopped working.

Manufacturer Narrative

Analysis of returned product revealed that the device has a kink in the catheter shaft, consequently confirming the reported catheter "difficult to withdraw" event.The catheter deployment/undeployment failure is not confirming the reported event since deployment slider functioned properly, and the basket shape was formed.No abnormal resistance was felt when executing the steering mechanism and deployment system.

Event Description

It was reported that an intellamap orion catheter during ablation on a patient with a complex vascular access, presented a deployment/undeployment failure, and was damaged at the moment of insertion.The catheter was removed from the patient's body and replaced with another one of the same type.The procedure then was completed without patient complications.The device is expected to be returned.It was further reported that no pictures were available.The patient was overweighted, and the physician had very difficult access to the right atrium through the femoral vein.On the way up, the orion got stuck and this meant that the orion could not be used.The array was unable to undeployed, so the catheter was removed with difficulties due to patient's anatomy.The orion mechanism was bent and the opening and closing of the orion stopped working.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18587960
• MDR Text Key: 334840036
• Report Number: 2124215-2024-04231
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729841968
• UDI-Public: 08714729841968
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K143481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 87035
• Device Catalogue Number: 87035
• Device Lot Number: 0032154360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1