BOSTON SCIENTIFIC CORPORATION INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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Model Number 87035 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 10/07/2021 |
Event Type
Injury
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Manufacturer Narrative
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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.
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Event Description
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Newton af clinical study.The index ablation procedure was completed on (b)(6) 2021.Access was gained via non-boston scientific access sheath(s), and unspecified non-boston scientific diagnostic catheter(s).Ablation was performed using three intellanav stablepoint catheters, mapping was also performed with an intellamap orion high resolution mapping catheter.No patient complications or product performance issues were reported.Three days following the index procedure, the patient experienced bloating and abdominal pain.Patient underwent ct-scan of the abdomen and blood work, which were "negative".Patient was given intravenous hydromorphone.Patient was discharged the same day.
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Event Description
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Newton af clinical study the index ablation procedure was completed on (b)(6) 2021.Access was gained via non-boston scientific access sheath(s), and unspecified non-boston scientific diagnostic catheter(s).Ablation was performed using three intellanav stablepoint catheters, mapping was also performed with an intellamap orion high resolution mapping catheter.No patient complications or product performance issues were reported.Three days following the index procedure, the patient experienced bloating and abdominal pain.Patient underwent ct-scan of the abdomen and blood work, which were "negative".Patient was given intravenous hydromorphone.Patient was discharged the same day.
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Manufacturer Narrative
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The device was returned to boston scientific for analysis.Visual inspection revealed no visual abnormalities.Functional testing revealed the device had stable signals and mapping was active during testing.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use (ifu).The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
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Search Alerts/Recalls
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