Model Number VERSION 1.0 |
Device Problems
Break (1069); Material Deformation (2976)
|
Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 06/12/2023 |
Event Type
Injury
|
Event Description
|
It was reported that during a recanalization procedure via right femoral, the helix allegedly fractured.It was further reported that the helix allegedly folded on itself making it unable to fit back into the sheath.Reportedly, a cut down procedure was done to retrieve the broken piece.The current status of the patient was unknown.
|
|
Manufacturer Narrative
|
H10: the medical device manufacturer (d3) and manufacturing location (g1) for the straub product was selected as unknown due to system limitations.The correct medical device manufacturer and manufacturing location are straub medical us.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 (expiry date: 11/2024).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.Device pending return.
|
|
Manufacturer Narrative
|
H10: the medical device manufacturer (d3) and manufacturing location (g1) for the straub product was selected as unknown due to system limitations.The correct medical device manufacturer and manufacturing location are straub medical us.H10: manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was returned for evaluation.A catheter was physically investigated.During physical intervention the helix was sent separated from the catheter and mounted on the guidewire.The flexible tip of the guidewire was deformed.The helix was broken at 71 cm from the tip of the catheter.There was a slight kink of the tube at 71 cm from the tip of the catheter.Therefore, the investigation is confirmed for the reported helix break and material deformation issues.A clear root cause could not be identified but a blockage of the catheter represents a known inherent risk.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.D4 (expiry date: 11/2024).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.
|
|
Event Description
|
It was reported that during a recanalization procedure via right femoral, the helix allegedly fractured.It was further reported that the helix allegedly folded on itself making it unable to fit back into the sheath.Reportedly, a cut down procedure was done to retrieve the broken piece.The current status of the patient was unknown.
|
|
Search Alerts/Recalls
|
|