|
Model Number U3513056 |
Device Problems
Difficult to Remove (1528); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
|
Patient Problems
Tachycardia (2095); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 05/19/2022 |
Event Type
Death
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
It was reported that during an angioplasty procedure, the device guidewire stuck and unable to retrieve back into the sheath.It was further reported that the balloon snapped off from the balloon catheter shaft and separated, leaving balloon portion inside the patient's right external illiac.There was no reported patient injury.
|
|
Manufacturer Narrative
|
H10: additional information was received and the file was reassessed for reportability and determined to be reportable as death.H10: 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.H10: g3 h11: b5, e1, 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.H3 other text : device not returned.
|
|
Event Description
|
It was reported that during an angioplasty procedure, the pta catheter became stuck on the guidewire and was unable to be retrieved back into the sheath.Upon retraction, the balloon detached from the catheter shaft.It was further reported, it was not visually confirmed if pta balloon was removed or left in patient.Patient experienced escalated heart rate, followed by usage of defibrillator.Patient was transferred to hospital.If was further reported, the patient expired the next day.
|
|
Search Alerts/Recalls
|
|
|