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

Model Number	M004R9620K20
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: "around (b)(6)".(b)(4).
Event or Problem Description
It was reported that there was a separation of a segment of the catheter.During a ventricular tachycardia (vt) ablation procedure with an intellanav oi ablation catheter, a separation of a segment of the catheter occurred in the patient's left ventricle.It didn't completely come apart from the catheter, but there was a separation in the shaft's material of the catheter near the upper distal third of the catheter.After the separation, two alarms occurred.The first alarm was they lost catheter visualization during ablation on the rythmia system.The second alarm was a high impedance alarm noted on the maestro 4000 rf generator.There was also noise on the distal ablation signals.No patient complications occurred.The procedure was not completed with another of the same device and the patient was fine.
Additional Manufacturer Narrative
Device evaluated by mfr: the unit returned had the distal tip damaged, as part of overall visual revision.Visual inspection revealed the device had a gap in the butt bond.The device had two bends located 5 cm - 9cm from the tip in the distal section.Functional inspection revealed the device was actuated finding an issue on the curves due to the bents located in the distal section.Lcr test was performed and the device was found without specification.The device failed the inductance test; it should be with 4.5 to 5.5 mh.Electrical test found no opens or shorts.Tip offset measurement revealed the device failed the tip offset test.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause has been determined to be manufacturing related.(b)(4).
Event or Problem Description
It was reported that there was a separation of a segment of the catheter.During a ventricular tachycardia (vt) ablation procedure with an intellanav oi ablation catheter, a separation of a segment of the catheter occurred in the patient's left ventricle.It didn't completely come apart from the catheter, but there was a separation in the shaft's material of the catheter near the upper distal third of the catheter.After the separation, two alarms occurred.The first alarm was they lost catheter visualization during ablation on the rythmia system.The second alarm was a high impedance alarm noted on the maestro 4000 rf generator.There was also noise on the distal ablation signals.No patient complications occurred.The procedure was not completed with another of the same device and the patient was fine.

• 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: 6346006
• Report Number: 2134265-2017-01172
• Device Sequence Number: 10970152
• Product Code: OAD
• UDI-Device Identifier: 08714729937449
• UDI-Public: (01)08714729937449(17)20190923(10)19777734
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2017

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: 09/23/2019
• Device Model Number: M004R9620K20
• Device Catalogue Number: R9620K2
• Device Lot Number: 19777734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/30/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2017
• Supplement Report FDA Received Date: 03/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1