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

Model Number	M004R9620K20
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during an ablation procedure, catheter irrigation ports were not irrigating properly.An intellanav oi ablation catheter was used during a procedure to treat flutter.Following delivery of ablation energy, ¿eventually¿ the irrigation pump alarmed and indicated an occlusion downstream.It was verified that everything was working correctly and an attempt was made to continue the procedure; however, the alarm indicating occlusion occurred again.The catheter was removed from the body and it was visually observed that the irrigation ports were not all irrigating properly.It was unknown how many of the ports were not irrigating, but some ports were producing seemingly normal streams of irrigation, while others were not.The physician inspected the catheter and wiped the tip, but irrigation did not improve.Another intellanav oi was used to complete the procedure, and it was noted the difference in irrigation spray was significant.There were no patient complications; the patient was ¿fine.¿.
Additional Manufacturer Narrative
Device evaluated by mfr: visual inspection of the returned device found several of the irrigation ports had a white substance, determined to be oxidized solder and saline residue, around the perimeter of the ports and in the tip, partially blocking the ports.The obstructions were securely attached to the tip.Internal cracks were observed in the luer; however, there did not appear to be any loose pieces.The device was connected to a metriq pump at a flow rate of 60 ml/min; it was confirmed only one of the six irrigation ports produced a normal spray, while one port produced partial spray and four ports produced droplets of saline.Microscopic inspection afterward confirmed the obstructions were still present in the ports.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is manufacturing execution error as the manufacturing process was not executed as validated/as designed.Updated: device evaluated by mfr.(b)(4).
Event or Problem Description
It was reported that during an ablation procedure, catheter irrigation ports were not irrigating properly.An intellanav oi ablation catheter was used during a procedure to treat flutter.Following delivery of ablation energy, ¿eventually¿ the irrigation pump alarmed and indicated an occlusion downstream.It was verified that everything was working correctly and an attempt was made to continue the procedure; however, the alarm indicating occlusion occurred again.The catheter was removed from the body and it was visually observed that the irrigation ports were not all irrigating properly.It was unknown how many of the ports were not irrigating, but some ports were producing seemingly normal streams of irrigation, while others were not.The physician inspected the catheter and wiped the tip, but irrigation did not improve.Another intellanav oi was used to complete the procedure, and it was noted the difference in irrigation spray was significant.There were no patient complications; 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: 7009790
• Report Number: 2134265-2017-11064
• Device Sequence Number: 1029499
• Product Code: OAE
• UDI-Device Identifier: 08714729937449
• UDI-Public: 08714729937449
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 10/19/2017

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: 01/11/2020
• Device Model Number: M004R9620K20
• Device Catalogue Number: R9620K2
• Device Lot Number: 20153526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2017
• Initial Date Received by Manufacturer: 10/19/2017
• Supplement Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 11/08/2017
• Supplement Report FDA Received Date: 02/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR