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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 Neurological Deficit/Dysfunction (1982); Transient Ischemic Attack (2109); Weakness (2145)
Event Date 03/26/2019
Event Type  Injury  
Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
 
Event Description
Localize clinical study: it was reported that the patient experienced an ischemic stroke.The event occurred during a three-month follow-up assessment procedure to the index study procedure.Access was obtained with an direx steerable sheath and a non-bsc sheath.Mapping was performed with an intellamap orion catheter and ablation was performed with an intellanav mifi open-irrigated ablation catheter.The patient presented with weakness on the left side and dysarthria.An ischemic stroke occurred.The activated clotting time (act) levels were 300-400 seconds during the procedure.The flow rate was programmed according to the directions for use (dfu).A computerized tomography (ct) was performed.The event outcome was reported as ongoing.
 
Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.Report source - corrected to include study.
 
Event Description
Localize clinical study.It was reported that the patient experienced an ischemic stroke.The event occurred during a three-month follow-up assessment procedure to the index study procedure.Access was obtained with an direx steerable sheath and a non-bsc sheath.Mapping was performed with an intellamap orion catheter and ablation was performed with an intellanav mifi open-irrigated ablation catheter.The patient presented with weakness on the left side and dysarthria.An ischemic stroke occurred.The activated clotting time (act) levels were 300-400 seconds during the procedure.The flow rate was programmed according to the directions for use (dfu).A computerized tomography (ct) was performed.The event outcome was reported as ongoing.It was further reported that the date of event was (b)(6) 2019 and the patient had to undergo physical therapy on (b)(6) 2019.The patient experienced "light difficult to speak" and permanent injury.His hospitalization stay was extended 2 days due to the event.The event was "probably to anti-coagulation management but could be related also to any products related during procedure." the device was in use for 1 hour and 48 minutes when the event occurred.There was no issue with the device.
 
Event Description
Localize clinical study.It was reported that the patient experienced an ischemic stroke.The event occurred during a three-month follow-up assessment procedure to the index study procedure.Access was obtained with an direx steerable sheath and a non-bsc sheath.Mapping was performed with an intellamap orion catheter and ablation was performed with an intellanav mifi open-irrigated ablation catheter.The patient presented with weakness on the left side and dysarthria.An ischemic stroke occurred.The activated clotting time (act) levels were 300-400 seconds during the procedure.The flow rate was programmed according to the directions for use (dfu).A computerized tomography (ct) was performed.The event outcome was reported as ongoing.It was further reported that the date of event was on (b)(6) 2019 and the patient had to undergo physical therapy on (b)(6) 2019.The patient experienced "light difficult to speak" and permanent injury.His hospitalization stay was extended 2 days due to the event.The event was "probably to anti-coagulation management but could be related also to any products related during procedure." the device was in use for 1 hour and 48 minutes when the event occurred.There was no issue with the device.It was further reported that since on (b)(6) 2019, the patient has had "chronic" physical therapy.The event was "not recovered/not resolved." it was further reported that the patient made a complete recovery without sequelae, confirmed at the 3-month follow-up neurologic assessment.The patient's pre-existing conditions consisted of multiple myeloma (igg kappa) that was being treated with lenalidomide and prednisone.
 
Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.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
300 boston scientific way
marlborough MA 01752
MDR Report Key8549213
MDR Text Key143052957
Report Number2134265-2019-04344
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,foreig
Type of Report Initial,Followup,Followup
Report Date 04/23/2020
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 Date01/10/2020
Device Model Number87035
Device Catalogue Number87035
Device Lot Number0023168562
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/28/2019
Initial Date FDA Received04/25/2019
Supplement Dates Manufacturer Received04/30/2019
04/14/2020
Supplement Dates FDA Received05/23/2019
04/23/2020
Patient Sequence Number1
Treatment
BOSTON SCIENTIFIC RHYTHMIA HDX; BOSTON SCIENTIFIC RHYTHMIA HDX; BOSTON SCIENTIFIC RHYTHMIA HDX; DIREX STEERABLE SHEATH; DIREX STEERABLE SHEATH; DIREX STEERABLE SHEATH; INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER; INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER; INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER; ST JUDE MEDICAL AGILISACCESS SHEATH; ST JUDE MEDICAL AGILISACCESS SHEATH; ST JUDE MEDICAL AGILISACCESS SHEATH; BOSTON SCIENTIFIC RHYTHMIA HDX; DIREX STEERABLE SHEATH; INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER; ST JUDE MEDICAL AGILISACCESS SHEATH
Patient Outcome(s) Hospitalization; Other; Disability;
Patient Age76 YR
Patient Weight77
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