BOSTON SCIENTIFIC CORPORATION BLAZER DX-20 DIAGNOSTIC CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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Model Number 86700 |
Device Problems
Difficult to Remove (1528); Positioning Problem (3009); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/06/2023 |
Event Type
malfunction
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Manufacturer Narrative
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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.
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Event Description
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It was reported that during the ablation procedure the catheter deflection issues occurred and could not be retracted right away.The catheter was inserted through the french pinnacle sheath, and advanced into the heart from the right femoral vein access.Under fluoroscopy it was seen that the catheter was retroflexed, and they attempted to manipulate mechanism, advance, and retract svc back into the femoral lane, but the catheter did not return to straight.Catheter was through the sheath.The catheter stayed stuck and could not be withdrawn at first.They advanced into the heart and pulled back into the femoral vein but did not improve the state.Then, with much effort, the catheter was successfully retracted and removed from the body through the 10f sheath.No patient complications occurred.A different device was used to complete the procedure.The device is expected to be returned for analysis.
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Manufacturer Narrative
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The returned blazer dx diagnostic catheter was analyzed, passed all tests performed, and exhibited normal device characteristics.The reported event was not confirmed.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.There is no evidence that the device was used in a manner inconsistent with the labelled indications/ifu.
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Event Description
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It was reported that during the ablation procedure the catheter deflection issues occurred and could not be retracted right away.The catheter was inserted through the french pinnacle sheath, and advanced into the heart from the right femoral vein access.Under fluoroscopy it was seen that the catheter was retroflexed, and they attempted to manipulate mechanism, advance, and retract svc back into the femoral lane, but the catheter did not return to straight.Catheter was through the sheath.The catheter stayed stuck and could not be withdrawn at first.They advanced into the heart and pulled back into the femoral vein but did not improve the state.Then, with much effort, the catheter was successfully retracted and removed from the body through the 10f sheath.No patient complications occurred.A different device was used to complete the procedure.The catheter has been received at boston scientific's post market laboratory where it is awaiting analysis.
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