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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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BOSTON SCIENTIFIC CORPORATION INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING Back to Search Results
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 04/13/2021
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 after mapping several times with the intellamap orion catheter during a supraventricular tachycardia ablation procedure, the physician tried removing the orion catheter from the patient's body.The catheter appeared undeployed on both the fluoroscopy and on the rhythmia.Despite the undeployed state, the physician had difficulty retracting the orion into the sheath.There were many attempts to deploy as well as advance the catheter, but they were all unsuccessful.After approximately 10 attempts, the physician was able to undeploy and retract the orion into the sheath, and remove it from the patient's body without further incident.A different catheter was used to complete the procedure.No patient complications were reported.
 
Event Description
It was reported that after mapping several times with the intellamap orion catheter during a supraventricular tachycardia ablation procedure, the physician tried removing the orion catheter from the patient's body.The catheter appeared undeployed on both the fluoroscopy and on the rhythmia.Despite the undeployed state, the physician had difficulty retracting the orion into the sheath.There were many attempts to deploy as well as advance the catheter, but they were all unsuccessful.After approximately 10 attempts, the physician was able to undeploy and retract the orion into the sheath, and remove it from the patient's body without further incident.A different catheter was used to complete the procedure.No patient complications were reported.
 
Manufacturer Narrative
The device was returned to boston scientific for analysis.Visual inspection noted that there was deformation near the distal tip.The device was inserted into the planarity tester for insertion and withdrawal testing.The device could not be advanced beyond the exit of the tester without exerting much force.It is unknown when the damage to the catheter occurred.Damage limited the ability to maneuver the catheter in the sheath.Mapping, detection and deployment testing was conducted, and after the device was unexpired, the orion was actively mapping.The damage did not affect mapping.Deployment did show on the workstation screen, and mapping capabilities were full functional.Lot number was not provided; therefore, a ship history of previous lots sent to the customer was reviewed.Device history record (dhr) review of the lots identified found no issues.
 
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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 Key11739003
MDR Text Key247930917
Report Number2134265-2021-05414
Device Sequence Number1
Product Code DRF
Combination Product (y/n)N
PMA/PMN Number
K143481
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 09/02/2021
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 Number87035
Device Catalogue Number87035
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/15/2021
Initial Date Manufacturer Received 04/13/2021
Initial Date FDA Received04/28/2021
Supplement Dates Manufacturer Received08/13/2021
Supplement Dates FDA Received09/02/2021
Patient Sequence Number1
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