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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 Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/26/2023
Event Type  malfunction  
Event Description
It was reported that during an atypical flutter procedure, an intellamap orion catheter was selected for use.The physician didnt feel very comfortable with the deflection, he decided to take the catheter out of the patient, and one of the splines of the catheter physically fractured when the catheter went into the sheath.The catheter was replaced, and procedure was completed with no patient complications reported.The device is expected to return for laboratory analysis.
 
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 during an atypical flutter procedure, an intellamap orion catheter was selected for use.The physician didnt feel very comfortable with the deflection, he decided to take the catheter out of the patient, and one of the splines of the catheter physically fractured when the catheter went into the sheath.The catheter was replaced, and procedure was completed with no patient complications reported.The device has been received at boston scientific post market laboratory.
 
Manufacturer Narrative
Intellamap orion catheter was evaluated by boston scientific.Visual inspection found the device has a spline detached, consequently confirming the reported event, and it may be related with some other factors such as: handling of the device, the technique used by the physician and normal procedural difficulties encountered during the procedure that could have possibly affected the device performance and its integrity.Therefore, this investigation is assigned a conclusion code of "adverse event related to procedure" which indicates that the adverse event occurred during the procedure and the device had no influence on the event.
 
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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
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 Key18084491
MDR Text Key327535449
Report Number2124215-2023-61890
Device Sequence Number1
Product Code DRF
UDI-Device Identifier08714729841968
UDI-Public08714729841968
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K143481
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/21/2023
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 Date04/06/2024
Device Model Number87035
Device Catalogue Number87035
Device Lot Number0030289219
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/26/2023
Initial Date FDA Received11/07/2023
Supplement Dates Manufacturer Received12/06/2023
Supplement Dates FDA Received12/21/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/06/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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