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

Model Number	M004R9620N40
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient age: (b)(6).(b)(4).The device was received for analysis after decontamination; the upn and lot number match those provided by the customer.The distal section of the returned device was twisted and a bend was identified approximately 3cm from the distal tip.Electrical testing was performed and no open or short circuits were identified.Tip offset measurements were performed, and offset values indicated the device is tracking.X-ray showed twisted wires along the distal tip.The steering knob and tension control knob functioned properly on both the lock and unlock positions; however, the device curves out of plane due to the twisted distal section.Visual inspection of the returned device also revealed the butt bond had been separated and there was dried blood inside.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
Reportable based on analysis completed july 13, 2017.It was reported that during an ablation procedure, after over four hours of use, the asymmetric curve intellanav oi ablation catheter stopped magnetically tracking.A standard curve intellanav oi ablation catheter was used to regain magnetic tracking and complete the procedure.The patient was not harmed in any way during the procedure; the patient was fine.However, returned device analysis revealed the butt bond had been separated and body fluid was identified inside.

• 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: 6763575
• Report Number: 2134265-2017-07491
• Device Sequence Number: 931980
• Product Code: OAD
• UDI-Device Identifier: 08714729937456
• UDI-Public: (01)08714729937456(17)20191024(10)19835409
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 07/13/2017

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: 10/24/2019
• Device Model Number: M004R9620N40
• Device Catalogue Number: R9620N4
• Device Lot Number: 19835409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2017
• Initial Report FDA Received Date: 08/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: IRRIGATION PUMP: BOSTON SCIENTIFIC METRIQ; MAPPING SYSTEM: BOSTON SCIENTIFIC RHYTHMIA; RECORDING SYSTEM: GE CARDIOLAB; RF GENERATOR: BOSTON SCIENTIFIC MAESTRO 4000