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); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2019

Event Type  malfunction  

Event Description

It was reported that the intellamap orion catheter would not completely close; a spline was stuck.The patient underwent an ablation procedure for atrial fibrillation.During mapping, when the orion catheter was inserted into the heart and out of the sheath, it was expanded and closed but would not close completely.It was removed from the patient's body at which time the splines were observed to be stuck on each other.It was also noted that resistance had been felt when withdrawing the catheter.There was no visible damage to the splines.The splines were released, and the catheter could open and close without issue, however, the physician elected to replace it to continue the procedure.There were no patient complications.

Event Description

It was reported that the intellamap orion catheter would not completely close; a spline was stuck.The patient underwent an ablation procedure for atrial fibrillation.During mapping, when the orion catheter was inserted into the heart and out of the sheath, it was expanded and closed but would not close completely.It was removed from the patient's body at which time the splines were observed to be stuck on each other.It was also noted that resistance had been felt when withdrawing the catheter.There was no visible damage to the splines.The splines were released, and the catheter could open and close without issue, however, the physician elected to replace it to continue the procedure.There were no patient complications.It was further reported that an non-boston scientific 8.5f sheath was used in conjunction with the catheter.The catheter position upon retraction into the sheath had been straight.It was noted that a trial catheter deployment had been performed prior to insertion into the patient and the catheter had not been removed and re-inserted into the patient during the procedure.The patient did not have any unusual cardiac anatomy.

Manufacturer Narrative

Device evaluated by manufacturer: visual inspection of the catheter showed that the deployment shaft was peeling and there was electrode damage and damage to the magnetic sensor body.During dimensional inspection there was no issue with deploying and un-deploying the array.Electrical testing was performed, and the catheter passed; the device could track, map and condition when connected to an hdx system.There were numerous wear/scratch marks along the deployment shaft and splines.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

Event Description

It was reported that the intellamap orion catheter would not completely close; a spline was stuck.The patient underwent an ablation procedure for atrial fibrillation.During mapping, when the orion catheter was inserted into the heart and out of the sheath, it was expanded and closed but would not close completely.It was removed from the patient's body at which time the splines were observed to be stuck on each other.It was also noted that resistance had been felt when withdrawing the catheter.There was no visible damage to the splines.The splines were released, and the catheter could open and close without issue, however, the physician elected to replace it to continue the procedure.There were no patient complications.It was further reported that an non-boston scientific 8.5f sheath was used in conjunction with the catheter.The catheter position upon retraction into the sheath had been straight.It was noted that a trial catheter deployment had been performed prior to insertion into the patient and the catheter had not been removed and re-inserted into the patient during the procedure.The patient did not have any unusual cardiac anatomy.

• Brand Name: INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8817473
• MDR Text Key: 151918745
• Report Number: 2134265-2019-08611
• Device Sequence Number: 1
• Product Code: DRF
• 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,Followup
• Report Date: 09/19/2019

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 Expiration Date: 02/15/2020
• Device Model Number: 87035
• Device Catalogue Number: 87035
• Device Lot Number: 0023355887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2019
• Initial Date Manufacturer Received: 06/25/2019
• Initial Date FDA Received: 07/23/2019
• Supplement Dates Manufacturer Received: 07/08/2019; 08/23/2019
• Supplement Dates FDA Received: 08/05/2019; 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AGILIS 8.5F SHEATH.; AGILIS 8.5F SHEATH.
• Patient Age: 66 YR
• Patient Weight: 66