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Catalog Number DL950J |
Device Problems
Disconnection (1171); Premature Activation (1484); Failure to Advance (2524); Connection Problem (2900); Device Dislodged or Dislocated (2923)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/10/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the denali jugular system products that are cleared in the us.The pro code and 510 k number for the denali jugular system products are identified in d2 and g4.H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiration date: 03/2026).H11: section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : device pending return.
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Event Description
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It was reported that during a vena cava filter placement procedure, the filter allegedly got deployed inside the sheath with complete resistance and loosened the control of the device.It was further reported that after finishing the procedure, it was noticed that the filter was disconnected from the system.The procedure was completed using another device.There was no reported patient injury.
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Manufacturer Narrative
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H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the denali jugular system products that are cleared in the us.The pro code and 510 k number for the denali jugular system products are identified in d2 and g4.H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one denali jugular delivery system kit was returned for evaluation.Upon visual evaluation, filter was noted partially exposed from the distal end of the storage tube.Upon functional testing, pusher catheter was used deploy the filter and legs were noted to be crossed.Therefore, based on the sample evaluation, the investigation is confirmed for the reported failure to advance and dislodged or dislocated issue as filter was partially exposed from the storage tube and the investigation is determined to be inconclusive for the reported connection problem due to nature of the device received.A definitive root cause for the reported failure to advance, dislodged or dislocated issue and connection problem and identified detachment issue could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 03/2026), g3.H11: section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Event Description
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It was reported that during a vena cava filter placement procedure, the filter allegedly got deployed inside the sheath with complete resistance and loosened the control of the device.It was further reported that after finishing the procedure, it was noticed that the filter was disconnected from the system.The procedure was completed using another device.There was no reported patient injury.
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Search Alerts/Recalls
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