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

Model Number	M004R9620N40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	08/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Same case as mdr id# 2134265-2017-08395 and 2134265-2017-08396.It was reported a pericardial effusion occurred.An intellamap orion¿ mapping catheter, polaris x¿ diagnostic catheter, and an intellanav oi ablation catheter were used during a pulmonary vein ablation procedure being conducted to treat atrial fibrillation.During the procedure the physician noticed a pericardial effusion.The physician felt the effusion occurred during mapping, but was uncertain which catheter caused or contributed to the event.It was noted there had been no device performance issues.A pericardiocentesis was performed and the patient underwent surgery to repair the hole.The patient was doing ¿very well¿ and was in stable condition.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was received for analysis following decontamination.The lot number of the returned device did not match the lot number originally reported.The device did not have any obvious visible defects.Continuity checks revealed no electrical opens or shorts, and all electrode, thermistor, and magnetic sensor resistances measured within specification.The steering knob and tension control knob functioned properly on both the lock and unlock positions.No abnormal resistance was felt when actuating the steering mechanism.Tip motion was evaluated and the device passed both the right and left curve tests.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).
Event or Problem Description
Same case as mdr id# 2134265-2017-08395 and 2134265-2017-08396.It was reported a pericardial effusion occurred.An intellamap orion¿ mapping catheter, polaris x¿ diagnostic catheter, and an intellanav oi ablation catheter were used during a pulmonary vein ablation procedure being conducted to treat atrial fibrillation.During the procedure the physician noticed a pericardial effusion.The physician felt the effusion occurred during mapping, but was uncertain which catheter caused or contributed to the event.It was noted there had been no device performance issues.A pericardiocentesis was performed and the patient underwent surgery to repair the hole.The patient was doing ¿very well¿ and was in stable condition.

• 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: 6824439
• Report Number: 2134265-2017-08397
• Device Sequence Number: 16160238
• Product Code: OAD
• UDI-Device Identifier: 08714729937456
• UDI-Public: (01)08714729937456(17)20191130(10)20106737
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: M004R9620N40
• Device Catalogue Number: R9620N4
• Device Lot Number: 20006508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2017
• Initial Date Received by Manufacturer: 08/04/2017
• Supplement Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 08/28/2017
• Supplement Report FDA Received Date: 10/12/2017
• 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: DIAGNOSTIC CATHETER: BOSTON SCIENTIFIC POLARIS X; GENERATOR: BOSTON SCIENTIFIC MAESTRO 3000; MAPPING CATHETER: BOSTON SCI INTELLAMAP ORION; MAPPING SYSTEM: BOSTON SCIENTIFIC RHYTHMIA; RECORDING SYSTEM: GE CARDIOLAB
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR