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Model Number M00535920 |
Device Problems
Break (1069); Difficult to Advance (2920)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/25/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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 mdr will be filed.
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Event Description
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It was reported to boston scientific corporation that an ultratome xl was used in the biliary duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the physician observed that it was difficult to advance the guidewire through the ultratome lumen.When the physician attempted to remove the guidewire, the cutting wire broke.Reportedly, there was no part of the device detached inside the patient.The procedure was completed with a second ultratome xl, using the same generator and active cord.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
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Manufacturer Narrative
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Block h6 (device codes): the problem code 1069 captures the reportable event of cutting wire broken.Block h10: visual examination of the returned device revealed that the cutting wire was in good condition.Additionally, test guidewire was loaded into the guidewire port and it advance as intended.The complaint device was not consistent with the reported event that the cutting wire broke.Analysis of the returned device determined that the device did not present any visual issue and it worked as intended.Additionally, the review includes visual, dimensional and functional evaluations, which showed no evidence of either the alleged issue or any defect that could have contributed to the reported event.Therefore, the most probable cause is no problem detected.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and from the information available, this device was used per the directions for use (dfu)/product label.
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Event Description
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It was reported to boston scientific corporation that an ultratome xl was used in the biliary duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the physician observed that it was difficult to advance the guidewire through the ultratome lumen.When the physician attempted to remove the guidewire, the cutting wire broke.Reportedly, there was no part of the device detached inside the patient.The procedure was completed with a second ultratome xl, using the same generator and active cord.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
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Search Alerts/Recalls
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