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

Model Number 87035

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Tissue Damage (2104)

Event Date 11/10/2020

Event Type  Injury  

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 a intellamap orion high resolution mapping catheter was used in a atrial fibrillation (afib) atrial flutter (afl) procedure.During the procedure the physician noted that the basket scratched out an unknown tissue and an unknown object was attached to the basket electrode.The procedure was completed using this device with no further patient complications being reported.

Event Description

It was reported that a intellamap orion high resolution mapping catheter was used in a atrial fibrillation (afib) atrial flutter (afl) procedure.During the procedure the physician noted that the basket scratched out an unknown tissue and an unknown object was attached to the basket electrode.The procedure was completed using this device with no further patient complications being reported.

Manufacturer Narrative

The device did show dried fluid on the basket near the equatorial plane.No electrodes had dried tissue occluding the pad.The device did not show any operational abnormalities in either planarity or curve.There was no structural damage noted during visual inspection.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.There is no evidence this device was used in a manner inconsistent with the labeled indications.

• 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: 10896489
• MDR Text Key: 218020965
• Report Number: 2134265-2020-16359
• 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: 01/27/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/23/2021
• Device Model Number: 87035
• Device Catalogue Number: 87035
• Device Lot Number: 0024819061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 11/24/2020
• Supplement Dates Manufacturer Received: 01/21/2021
• Supplement Dates FDA Received: 01/27/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR