BOSTON SCIENTIFIC CORPORATION HABIB ENDOHPB; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
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Model Number M00500070 |
Device Problem
Failure to Deliver Energy (1211)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/28/2022 |
Event Type
malfunction
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Event Description
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It was reported to boston scientific corporation on (b)(6) 2022 that an endohpb rf catheter was used in the bile duct for stent ingrowth during an endoscopic retrograde cholangiopancreatography (ercp) with radiofrequency ablation procedure performed on (b)(6) 2022.The patient's anatomy was not dilated prior to first attempt at ablation.During the procedure, the habib catheter was unable to deliver energy.The device was repositioned and the power setting was increased; however, the habib catheter was still unable to work.The procedure was cancelled due to device availability.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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(b)(4).
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Manufacturer Narrative
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H6: impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.H10: a habib endohpb catheter was received for analysis.Visual inspection found the electrical wire deformed during assembly.During electrical testing, the electrical wire was weakened and broken.The green wire from distal electrode was broken near the electrode welding.The security wire was not broken before disassembly but it broke during analysis.No other problems were noted to the catheter.The reported event of device failure to deliver energy was confirmed and was traced to the manufacturing process.The electrical cable was found deformed and it likely occurred during assembly.An investigation to address this issue is in progress.Therefore, a review and analysis of all available information indicated the most probable cause is manufacturing deficiency.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.G4 (premarket/510k #) has been corrected.
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Event Description
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It was reported to boston scientific corporation on november 28, 2022 that an endohpb rf catheter was used in the bile duct for stent ingrowth during an endoscopic retrograde cholangiopancreatography (ercp) with radiofrequency ablation procedure performed on (b)(6) 2022.The patient's anatomy was not dilated prior to first attempt at ablation.During the procedure, the habib catheter was unable to deliver energy.The device was repositioned and the power setting was increased; however, the habib catheter was still unable to work.The procedure was cancelled due to device availability.There were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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