Catalog Number LSM1350658 |
Device Problems
Device Dislodged or Dislocated (2923); Packaging Problem (3007)
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Patient Problems
Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
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Event Date 09/03/2020 |
Event Type
Injury
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Manufacturer Narrative
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As the lot number for the device was provided, a manufacturing review will 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.(expiry date: 01/2022).
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Event Description
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It was reported that during a stent placement procedure, the device allegedly detached from the balloon.The detached device was removed after prolonged hospitalization.The current status of the patient is unknown.
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Manufacturer Narrative
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H10: manufacturing review: a complaint history review was performed.This is the first complaint reported for this product/lot number combination.Investigation summary:the sample was not returned for evaluation.The investigation is inconclusive for the dislodgement and packaging issues reported.The definitive root cause for the reported dislodgement and packaging issues could not be determined based upon information received from the field communications.Labeling review: the instructions for use for the lifestream product was reviewed and contains the following information relevant to the reported event: precautions.The device should only be used by physicians who are trained in endovascular procedures and are familiar with the complications, side effects and hazards of peripheral vascular interventions.Prior to device use, refer to the covered stent sizing table on the label and read the instructions for use.Crossing the implant with catheters or other adjunct devices can result in covered stent dislodgement or damage.Potential patient/device adverse effects that may occur include, but are not limited to, the following: covered stent dislodgement from balloon during tracking procedure.Covered stent misplacement during placement procedure.Directions for use: site access and preparation.Using standard techniques access the artery and place an introducer sheath or guiding catheter of appropriate inner diameter and a 0.035" (0.89 mm) guidewire across the target lesion.Covered stent size selection.Select a covered stent diameter that is approximately 5%-20% larger than the largest reference vessel diameter at the proximal or distal target site.Refer to the sizing table on the packaging label for appropriate selection of the covered stent diameter and length.Endovascular system preparation.Carefully remove the selected device from the package.Inspect the covered stent for adherence to the balloon and centered placement in relation to the balloon marker bands.If the covered stent is not centered and/or does not firmly adhere to the balloon, do not use.Flush the delivery system guidewire lumen with sterile saline mixture until saline drops from the distal end of the endovascular system.Air evacuation.A 20 cc or smaller luer-lock syringe with a minimum of 5 cc¿s sterile saline mixture is recommended for use for aspirating this device.With the distal balloon tip pointing down and positioned below the level of the syringe, pull negative pressure until all air is expelled.Induce a negative pressure to remove any air from the balloon and inflation lumen.Repeat until all air is expelled.10.Carefully release to neutral.Allow the inflation lumen to fill with the diluted contrast medium and maintain a neutral pressure.Important: do not apply positive pressure to the balloon.Attach the prefilled inflation device to the inflation lumen of the catheter hub, ensuring no air bubbles remain at the catheter connection.Verify that the covered stent is still centered between the two radiopaque markers on the balloon catheter.Introduction of the endovascular system and placement of the covered stent advance the endovascular system over the guidewire into the introducer sheath.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the life stream products that are cleared in the us.The pro code and 510 k number for the life stream products are identified in d2 and g5.H10: d4 (expiry date: 01/2022),g4.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 stent placement procedure, the device allegedly detached from the balloon.It was further reported that the device could not be removed from the patient and therefore the patient required prolonged hospitalization due to the event.It was further reported that the packaging of the product was not adequate, the box bended and the tips were deformed at the time of removal.The current status of the patient is unknown.
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Event Description
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It was reported that during a stent placement procedure, the device allegedly detached from the balloon.It was further reported that the device could not be removed from the patient and therefore the patient required prolonged hospitalization due to the event.The current status of the patient is unknown.
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Manufacturer Narrative
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H10: manufacturing review: a manufacturing review was not required as this was the first complaint reported for this lot number.Investigation summary: the sample was not returned for evaluation.The investigation is inconclusive for the dislodgement issue reported.The definitive root cause for the reported dislodgement issue could not be determined based upon information received from the field communications.Labeling review: 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.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the life stream products that are cleared in the us.The pro code and 510 k number for the life stream products are identified in d2 and g5.
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Search Alerts/Recalls
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