MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLANAV OPEN-IRRIGATED; INTELLANAV OI

Model Number	87045
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Death (1802); Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); ST Segment Elevation (2059); Vasoconstriction (2126); Ventricular Tachycardia (2132); Perforation of Vessels (2135)
Date of Event	02/05/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported a patient death occurred.The iliac artery was perforated, and the patient experienced a retroperitoneal bleed and hematoma.Symptoms secondary to blood loss included: low blood pressure, st segment elevation, twitching of the right coronary artery, and incessant ventricular tachycardia (vt).An intellamap orion mapping catheter, an intellanav oi ablation catheter, and another manufacturer's short sheath were selected for use during an ischemic ventricular tachycardia ablation procedure.Access was gained in the left and right femoral veins and the right femoral artery, with ultrasonic guidance.A short sheath was placed in the femoral artery and the mapping catheter was advanced without issue.After mapping for about 20 minutes the catheter was removed, also without issue.The intellanav oi ablation catheter was then inserted into the sheath, and the physician felt resistance.Initially it was reported that the physician realized on fluoroscopy that the catheter had a kink in it; however, it was later reported that the catheter had been kinked prior to insertion into the patient's body.Due to the kink, the physician requested a new ablation catheter.At that time, he also replaced the short sheath with a another manufacturer's long sheath.A second intellanav oi ablation catheter was advanced.The physician did not mention whether he continued to meet resistance.Within 20 seconds of inserting the second ablation catheter, blood pressure was dropping rapidly.Transthoracic ultrasound ruled out effusion.At this time, st segment elevation (right coronary pattern) was observed and an angiogram was performed.The right coronary artery was observed to be twitching, but no occlusion was found; therefore, no intervention took place.At the time of the angiogram, the patient was in incessant vt and required sustained defibrillations and chest compressions.Creatinine measured 15 mmol/l indicating a possible internal bleed.An aortogram ruled out aortic dissection; however, computed tomography (ct) revealed a retroperitoneal bleed and hematoma.The patient was sent to the operating room but passed away.The cause of death was blood loss.The physician initially reported the iliac artery was pierced while exchanging the short sheath for a long sheath; however, it was later reported that the perforation occurred during placement of the mapping catheter.There was no evidence of damage on the sheath.It was reported there were no product deficiencies which may have caused or contributed to the patient's complications.
Additional Manufacturer Narrative
Device evaluated by manufacturer: visual inspection of the returned device revealed a slight bend at ring 1 and another bend immediately distal from the butt bond.Tip motion was evaluated and both the right and left curves were 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.X-ray confirmed bends in the center support near the butt bond and at the distal tip.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
Event or Problem Description
It was reported a patient death occurred.The iliac artery was perforated, and the patient experienced a retroperitoneal bleed and hematoma.Symptoms secondary to blood loss included: low blood pressure, st segment elevation, twitching of the right coronary artery, and incessant ventricular tachycardia (vt).An intellamap orion mapping catheter, an intellanav oi ablation catheter, and another manufacturer's short sheath were selected for use during an ischemic ventricular tachycardia ablation procedure.Access was gained in the left and right femoral veins and the right femoral artery, with ultrasonic guidance.A short sheath was placed in the femoral artery and the mapping catheter was advanced without issue.After mapping for about 20 minutes the catheter was removed, also without issue.The intellanav oi ablation catheter was then inserted into the sheath, and the physician felt resistance.Initially it was reported that the physician realized on fluoroscopy that the catheter had a kink in it; however, it was later reported that the catheter had been kinked prior to insertion into the patient's body.Due to the kink, the physician requested a new ablation catheter.At that time, he also replaced the short sheath with a another manufacturer's long sheath.A second intellanav oi ablation catheter was advanced.The physician did not mention whether he continued to meet resistance.Within 20 seconds of inserting the second ablation catheter, blood pressure was dropping rapidly.Transthoracic ultrasound ruled out effusion.At this time, st segment elevation (right coronary pattern) was observed and an angiogram was performed.The right coronary artery was observed to be twitching, but no occlusion was found; therefore, no intervention took place.At the time of the angiogram, the patient was in incessant vt and required sustained defibrillations and chest compressions.Creatinine measured 15 mmol/l indicating a possible internal bleed.An aortogram ruled out aortic dissection; however, computed tomography (ct) revealed a retroperitoneal bleed and hematoma.The patient was sent to the operating room but passed away.The cause of death was blood loss.The physician initially reported the iliac artery was pierced while exchanging the short sheath for a long sheath; however, it was later reported that the perforation occurred during placement of the mapping catheter.There was no evidence of damage on the sheath.It was reported there were no product deficiencies which may have caused or contributed to the patient's complications.

• Brand Name: INTELLANAV OPEN-IRRIGATED
• Common Device Name: INTELLANAV OI
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8394326
• Report Number: 2134265-2019-02084
• Device Sequence Number: 1436517
• Product Code: OAD
• UDI-Device Identifier: 08714729937449
• UDI-Public: 08714729937449
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P150005/S005
• 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): 05/29/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/13/2021
• Device Model Number: 87045
• Device Catalogue Number: 87045
• Device Lot Number: 0021861312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Initial Date Received by Manufacturer: 02/05/2019
• Supplement Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 05/29/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ABLATION CATHETER: BSC INTELLANAV OI; ABLATION CATHETER: BSC INTELLANAV OI; LONG SHEATH: CORDIS BRITE TIP, 9F 23CM; LONG SHEATH: CORDIS BRITE TIP, 9F 23CM; MAPPING CATHETER: BSC INTELLAMAP ORION; MAPPING CATHETER: BSC INTELLAMAP ORION; SHORT SHEATH: CORDIS AVANTI+, 9F 11CM; SHORT SHEATH: CORDIS AVANTI+, 9F 11CM; ABLATION CATHETER: BSC INTELLANAV OI; LONG SHEATH: CORDIS BRITE TIP, 9F 23CM; MAPPING CATHETER: BSC INTELLAMAP ORION; SHORT SHEATH: CORDIS AVANTI+, 9F 11CM
• Outcome Attributed to Adverse Event: Death; Life Threatening; Required Intervention