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Catalog Number CRE14S |
Device Problems
Fracture (1260); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
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Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/14/2021 |
Event Type
Injury
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Manufacturer Narrative
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As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer.The investigation of the reported event is currently underway.The catalog number identified has not been cleared in the us but is similar to the crosser cto recanalization catheter products that are cleared in the us.The pro code and 510 k number for the crosser cto recanalization catheter products are identified.(expiry date: 03/2023).
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Event Description
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It was reported that during a recanalization procedure in the anterior tibial artery, the core wire allegedly had fracture and detachment.It was further reported that the tip of the wire was reported to be inside the patient body.There was no reported patient injury.
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Manufacturer Narrative
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H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer.The investigation of the reported event is currently underway.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the crosser cto recanalization catheter products that are cleared in the us.The pro code and 510 k number for the crosser cto recanalization catheter products are identified in d2 and g4.H10: d4 (expiry date: 03/2023), g3 h11: b5, h1, h6(patient).H11:section a through f - the information provided by bd represents all of 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 recanalization procedure in the anterior tibial artery, the core wire allegedly had fracture and detachment.It was further reported that the tip of the wire was reported to be inside the patient body.The current status of the patient is unknown.
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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 crosser cto recanalization catheter products that are cleared in the us.The pro code and 510 k number for the crosser cto recanalization catheter 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 14s crosser cto recanalization catheter was returned.During visual evaluation, no anomalies were noted to the transducer handle or saline hub.The distal marker band was attached outer catheter.The core wire was fractured proximal to the marker band and the distal end was not returned.Moreover, tears were noted throughout the outer catheter.Therefore, the investigation is confirmed for tip detachment and torn material.A definitive root cause for the reported tip detachment and identified torn material issue could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 03/2023), g3, h6 (method).H11: b5, h6 (device, result, conclusion).H11:section a through f - the information provided by bd represents all of 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 recanalization procedure in the anterior tibial artery, the core wire allegedly had detachment.It was further reported that the tip of the wire was remained in patient body.The patient status was unknown.
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Search Alerts/Recalls
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