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

Model Number M004EPTR96200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Arrhythmia (1721); Dyspnea (1816); Fatigue (1849); Low Blood Pressure/ Hypotension (1914)

Event Date 12/19/2016

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mdr id#2134265-2017-00013.It was reported that during the procedure hypotension occurred and following the procedure pulmonary embolism occurred.The procedure was indicated due to atrial fibrillation and atrial flutter.During the procedure, there was a "short time" that the flushing of the intellamap orion catheter was not turned on.The physician checked the catheter and inserted it again as there was no clotting visible.The patient had a blood pressure drop after the initial right atrium (ra) map and cavo-tricuspid isthmus (cti) ablation.Ablation was performed with an intellanav oi catheter.A stat echo was performed and no effusion was noted.The physicians elected to continue with the case.The went transeptal and completed the pulmonary vein isolation (pvi) ablation.Nothing visibly wrong with either catheter was noted at the time of the procedure.The procedure was noted to be "very long", over 5 hours in length.Immediately after the procedure, the patient was tired but otherwise ok.The patient was noted to be in good condition.After discharge, when walking uphill, the patient realized dyspnea symptoms and feeling of lack of oxygen.Some arrhythmia sensations were also present.Two days later, the patient had dyspnea.Six days following the procedure, the patient returned to the hospital where a ct scan revealed right sided pulmonary embolism.In the physician's opinion, he pulmonary embolism was caused by catheters and sheets on the right side of the heart.Doppler ultrasound of the lower extremities was normal.The pulmonary embolism was treated by continuing warfarin.When returning to the hospital inr was 2.7.The patient is currently doing fine and prognosis is good.

• Brand Name: INTELLANAV OI
• Type of Device: INTELLANAV OI
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6259583
• MDR Text Key: 65032231
• Report Number: 2134265-2017-00012
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 10/24/2019
• Device Model Number: M004EPTR96200
• Device Catalogue Number: EPTR9620
• Device Lot Number: 19811547
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2016
• Initial Date FDA Received: 01/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR