MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) INTELLAMAP ORION¿; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number M004RC64S0

Device Problem Device Sensing Problem (2917)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: visual inspection shows an abnormal shape to the deployment array.The deployment shaft is peeling.Here is evidence of damage to the proximal end of the basket observed on multiple splines.Evidence of damage to multiple electrodes across all splines.The electrical test was performed and the device failed the test.Magnetic sensor resistance and inductance testing revealed both pairs are within specification.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is user / use error as there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer or expected by the user.The dfu states: "warnings:.¿ do not operate the catheter against resistance.If resistance is felt during advancement, retraction, articulation, deployment or un-deployment, stop and evaluate device location under fluoroscopy.¿ do not advance or retract the catheter through a sheath when deployed or articulated." and "precautions:.Always undeploy the catheter prior to removal from the patient.Use visualization (such as fluoroscopy) to verify undeployment.Always move the articulation control lever to its neutral position to straighten the catheter prior to removal from the patient.When used with a steerable guiding introducer sheath: ensure under fluoroscopy that the guiding introducer sheath distal end is straight or, if necessary, only minimally curved prior to advancing or retracting the catheter through the sheath.Do not articulate the sheath while the catheter array is inside the articulating section.Do not deploy or articulate the catheter while the distal end is inside a sheath.Remove the catheter in case of any observed malfunction." (b)(4).

Event Description

Reportable based on device analysis completed on 11april2018.A intellamap orion was selected for a procedure however, it was reported that during the procedure there were difficulties with the catheter signal while mapping.However; returned device analysis revealed peeling of the deployment shaft.

• Brand Name: INTELLAMAP ORION¿
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7497950
• MDR Text Key: 107709532
• Report Number: 2134265-2018-03649
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2018

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: 07/17/2018
• Device Model Number: M004RC64S0
• Device Catalogue Number: RC64S
• Device Lot Number: 20896904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/11/2018
• Initial Date FDA Received: 05/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2017
• 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