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 Obstruction of Flow (2423)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/10/2020

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

During a pulmonary vein isolation (pvi) ablation procedure a intellamap orion catheter was selected for use.It was reported that catheter was not able to be irrigated or flushed using a pressure bag.The irrigation port was blocked and could only be flushed with high pressure via a syringe.No error messages were observed irrigation difficulty was resolved by using an irrigation pump with a minimal flow, which the physician decided to use for flushing.The catheter flushed properly while using the irrigation pump and the physician proceeded to use the orion to complete the procedure.No patient complications were noted.

Manufacturer Narrative

No visible anomalies were noted via visual inspection.Catheter could not be irrigated/ flushed using a pressure bag, irrigation cannula of the catheter blocked and could only be flushed using high pressure in the beginning using a syringe manually.The obstruction was cleared after putting the device on the leak tester.After the obstruction was cleared the device was able to irrigate using an irrigation pump.The reason for the obstruction could not be identified.There is no evidence this device was used in a manner inconsistent with the labeled indications.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

Event Description

During a pulmonary vein isolation (pvi) ablation procedure a intellamap orion catheter was selected for use.It was reported that catheter was not able to be irrigated or flushed using a pressure bag.The irrigation port was blocked and could only be flushed with high pressure via a syringe.No error messages were observed irrigation difficulty was resolved by using an irrigation pump with a minimal flow, which the physician decided to use for flushing.The catheter flushed properly while using the irrigation pump and the physician proceeded to use the orion to complete the procedure.No patient complications were noted.

• 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: 11124628
• MDR Text Key: 225333178
• Report Number: 2134265-2020-18812
• 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: 03/03/2021

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: 03/30/2022
• Device Model Number: 87035
• Device Catalogue Number: 87035
• Device Lot Number: 0026092939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Initial Date Manufacturer Received: 12/10/2020
• Initial Date FDA Received: 01/06/2021
• Supplement Dates Manufacturer Received: 02/05/2021
• Supplement Dates FDA Received: 03/04/2021
• Patient Sequence Number: 1