MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SAN JOSE INTELLAMAP ORION?; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number M004RC64S0

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2015

Event Type  malfunction  

Event Description

It was reported that following the procedure, foreign material was found.The intellamap orion¿ was used in a persistent atrial fibrillation procedure.The orion was introduced into the left atrium using a non-bsc steerable introducer.Irrigation of the orion was performed with a heparinized saline solution, and worked fine at the end of the procedure.The orion was used instead of a circular catheter and in the same time for the disconnection of four pulmonary veins.The procedure time was 200 minutes, radiofrequency time 34 minutes, fluoroscopy time 62 minutes.Upon removal of the orion catheter the physician noted a biological white gelatinous substance was noticed on the internal part of at least two branches of the orion catheter.The physician did not identify the viscous and slightly sticky substance as being part of the cardiac tissue or of the coagulum.No patient complications were reported and the patient's status is stable.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Device evaluated by manufacturer - unit presents adherent material in the array.Decontamination can not be performed to avoid losing evidence.A white stain on spline #1 foreign matter on spline #7.All the splines are peeled and scratched in the golden area over the electrode #5.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).

Event Description

It was reported that following the procedure, foreign material was found.The intellamap orion was used in a persistent atrial fibrillation procedure.The orion was introduced into the left atrium using a non-bsc steerable introducer.Irrigation of the orion was performed with a heparinized saline solution, and worked fine at the end of the procedure.The orion was used instead of a circular catheter and in the same time for the disconnection of four pulmonary veins.The procedure time was 200 minutes, radiofrequency time 34 minutes, fluoroscopy time 62 minutes.Upon removal of the orion catheter the physician noted a biological white gelatinous substance was noticed on the internal part of at least two branches of the orion catheter.The physician did not identify the viscous and slightly sticky substance as being part of the cardiac tissue or of the coagulum.No patient complications were reported and the patient's status is stable.

• Brand Name: INTELLAMAP ORION?
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC - SAN JOSE; 150 baytech drive; san jose CA 95134
• Manufacturer (Section G): BOSTON SCIENTIFIC - SAN JOSE; 150 baytech drive; san jose CA 95134
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4480082
• MDR Text Key: 5501582
• Report Number: 2134265-2015-00194
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K122461
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2015
• Device Model Number: M004RC64S0
• Device Catalogue Number: RC64S
• Device Lot Number: 17328187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: INTRODUCER: AGILIS