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 Detachment of Device or Device Component (2907)

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

Event Date 03/30/2021

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 a intellamap orion high resolution mapping catheter was used in a pulmonary vein isolation procedure.It was noted that during the procedure the orion intellamap orion tangled with a non-boston scientific ablation catheter.At the end of the procedure when the catheter was removed from the patient, it was noted that a pull wire was protruding from the orion catheter.No patient complications were reported.The device is expected to be returned for analysis.

Event Description

It was reported that a intellamap orion high resolution mapping catheter was used in a pulmonary vein isolation procedure.It was noted that during the procedure the orion intellamap orion tangled with a non-boston scientific ablation catheter.At the end of the procedure when the catheter was removed from the patient, it was noted that a pull wire was protruding from the orion catheter.No patient complications were reported.The device is expected to be returned for analysis.

Manufacturer Narrative

Visual inspection of the device showed kink in the deployment shaft sticking out of the array.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: 11651037
• MDR Text Key: 244972259
• Report Number: 2134265-2021-04723
• 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
• Report Date: 06/24/2021

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 Expiration Date: 06/22/2022
• Device Model Number: 87035
• Device Catalogue Number: 87035
• Device Lot Number: 0026552949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Initial Date Manufacturer Received: 03/30/2021
• Initial Date FDA Received: 04/12/2021
• Supplement Dates Manufacturer Received: 06/16/2021
• Supplement Dates FDA Received: 06/24/2021
• Patient Sequence Number: 1