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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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BOSTON SCIENTIFIC CORPORATION INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING Back to Search Results
Model Number 87035
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Hematoma (1884); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); ST Segment Elevation (2059); Vasoconstriction (2126); Ventricular Tachycardia (2132); Perforation of Vessels (2135)
Event Date 02/05/2019
Event Type  Death  
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 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 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.
 
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 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 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.
 
Event 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 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.
 
Manufacturer Narrative
Device evaluated by manufacturer: visual inspection of the returned device revealed a kink approximately 5.5cm from the distal tip.Electrical testing was performed and the device passed the test.The device passed a curve test and there was no issue deploying or undeploying the array.The device passed all relevant testing/inspection.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
 
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Brand Name
INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER
Type of Device
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key8394312
MDR Text Key137943566
Report Number2134265-2019-02086
Device Sequence Number1
Product Code DRF
UDI-Device Identifier08714729841968
UDI-Public08714729841968
Combination Product (y/n)N
PMA/PMN Number
K143481
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 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? No
Device Operator Health Professional
Device Expiration Date05/24/2019
Device Model Number87035
Device Catalogue Number87035
Device Lot Number0022164697
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/18/2019
Initial Date Manufacturer Received 02/05/2019
Initial Date FDA Received03/06/2019
Supplement Dates Manufacturer Received02/05/2019
05/02/2019
Supplement Dates FDA Received03/06/2019
05/29/2019
Patient Sequence Number1
Treatment
ABLATION CATHETERS: BSC INTELLANAV OI; ABLATION CATHETERS: BSC INTELLANAV OI; ABLATION CATHETERS: BSC INTELLANAV OI; LONG SHEATH: CORDIS BRITE TIP, 9F 23CM; LONG SHEATH: CORDIS BRITE TIP, 9F 23CM; LONG SHEATH: CORDIS BRITE TIP, 9F 23CM; SHORT SHEATH: CORDIS AVANTI+, 9F 11CM; SHORT SHEATH: CORDIS AVANTI+, 9F 11CM; SHORT SHEATH: CORDIS AVANTI+, 9F 11CM; ABLATION CATHETERS: BSC INTELLANAV OI; LONG SHEATH: CORDIS BRITE TIP, 9F 23CM; SHORT SHEATH: CORDIS AVANTI+, 9F 11CM
Patient Outcome(s) Death; Life Threatening; Required Intervention;
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