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Model Number ATG120186 |
Device Problems
Deflation Problem (1149); Entrapment of Device (1212); Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907)
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Patient Problems
Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 08/17/2022 |
Event Type
Injury
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Manufacturer Narrative
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As the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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 an angioplasty procedure through right femoral vein, the balloon was allegedly ruptured and sheared off the catheter.It was further reported that the balloon catheter was allegedly prepped outside the body.It was further reported that the balloon allegedly failed to deflate despite several attempts and could not be withdrawn from the sheath.Reportedly, the balloon catheter sheared off the catheter inside the patient and was stuck in the common femoral vein.Surgical removal of the balloon was performed to remove the balloon.The current status of the patient was not known.
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Manufacturer Narrative
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H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the device was not returned for evaluation.Medical records were not provided.Therefore, the investigation is inconclusive for the reported failures as no objective evidence was provided for review.A definitive root cause could not be determined based upon the available 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 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 an angioplasty procedure through right femoral vein, the balloon was allegedly ruptured at 6 atm and sheared off the catheter.It was further reported that the balloon catheter was allegedly prepped outside the body.It was further reported that the balloon allegedly failed to deflate despite several attempts and could not be withdrawn from the sheath.Reportedly, the balloon catheter sheared off the catheter inside the patient and was stuck in the common femoral vein.Reportedly, the device was not retrieved from the patient and the balloon was left inside the patient with the complications.The current status of the patient was not known.
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Search Alerts/Recalls
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