MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) INTELLANAV OI

Model Number	M004R9620N40
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer- inspection shows dried saline on the tip, adhesive along all electrode rings in the distal section and a blueish white substance on electrode ring #2.A review of the materials and processes used to manufacture the device did not determine a probable identification of the blueish white substance.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 or Problem Description
Reportable based on analysis completed on 14 august 2017.It was reported that there was noise electrogram (egm).During a left atrial flutter case the physician was unable to perform a pulmonary vein isolation (pvi) due to noise in the egm.The bard ground cable was disconnected and the patient ground cables were routed over the patient as recommended.No patient complications were reported.However; returned device analysis revealed foreign material on the catheter.

• Brand Name: INTELLANAV OI
• Common Device Name: INTELLANAV OI
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• MDR Report Key: 6813215
• Report Number: 2134265-2017-08635
• Device Sequence Number: 138816
• Product Code: OAD
• UDI-Device Identifier: 08714729937456
• UDI-Public: (01)08714729937456(17)20200427(10)0020553555
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P150005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/27/2020
• Device Model Number: M004R9620N40
• Device Catalogue Number: R9620N4
• Device Lot Number: 0020553555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2017
• Initial Report FDA Received Date: 08/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1