Catalog Number 5F051203C |
Device Problems
Break (1069); Premature Activation (1484); Detachment of Device or Device Component (2907); Material Deformation (2976)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/28/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
The catalog number identified has not been cleared in the u.S.But, it is similar to the lifestent 5f vascular stent system products that are cleared in the us.The 510 k number and pro code for the lifestent 5f vascular stent system products are identified in common device name and pma/510 k.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.Expiry date: 01/2024.
|
|
Event Description
|
It was reported that during a stent placement procedure, the green sheath was allegedly dislodged.The procedure was completed using another device.There was no reported patient injury.
|
|
Manufacturer Narrative
|
H10: the catalog number identified in section d4 has not been cleared in the u.S.But, it is similar to the lifestent 5f vascular stent system products that are cleared in the us.The 510 k number and pro code for the lifestent 5f vascular stent system products are identified in d2 and g4.H10: manufacturing review: lot history records of the lot number were reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.Investigation summary: the delivery system was returned for evaluation.The proximal end of the catheter was found broken close to the grip, and the stability sheath was detached from the kink protection but still over the proximal sheath which leads to confirmed result for break and detachment.The deployment system was found in actively used condition, and the stent was partially deployed, even though there was no reported attempt to deploy the stent; therefore a premature deployment cannot be reproduced.It was not known when the user activated the deployment mechanism.Based on evaluation of the delivery system and event information provided, breakage of the proximal end of the catheter as well as detachment of the stability sheath is confirmed.However, a definite root cause for the reported event could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.The instructions for use state: 'if resistance is met during stent system introduction, the stent system should be withdrawn and another stent system should be used.', and 'if resistance is met while retracting the delivery system over a guidewire, remove the delivery system and guidewire together.' the instructions for use further state: 'gain ipsilateral or contralateral femoral access utilizing an appropriate introducer sheath ¿ 5f (1.67 mm) or larger introducer sheath (.) insert a guidewire of appropriate length (table 2) and 0.014-inch (0.36 mm) - 0.035-inch (0.89 mm) diameter across the lesion to be stented via the introducer sheath.' in regard to pta the instructions for use state: 'pre-dilatation of the lesion with a balloon dilatation catheter is recommended.' in regard to damage the instructions for use state: 'examine the stent system for any damage.If it is suspected that the sterility or performance of the stent system has been compromised, the device should not be used'.H10: b5, d4 (expiry date: 01/2024), g3, h6 (device) h11: h6 (method, 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.
|
|
Event Description
|
It was reported that during a stent placement procedure via contralateral common femoral, the outer sheath was allegedly detached.It was further reported that the green outer sheath was allegedly deformed.The procedure was completed using another device.There was no reported patient injury.
|
|
Manufacturer Narrative
|
H10: the catalog number identified in section d4 has not been cleared in the u.S.But, it is similar to the lifestent 5f vascular stent system products that are cleared in the us.The 510 k number and pro code for the lifestent 5f vascular stent system products are identified in d2 and g4.H10: manufacturing review: lot history records of the lot number were reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.Investigation summary: the delivery system was returned for evaluation.The proximal end of the catheter was found broken close to the grip, and the stability sheath was detached from the kink protection but still over the proximal sheath which leads to confirmed result for break and detachment.The deployment system was found in actively used condition, and the stent was partially deployed, even though there was no reported attempt to deploy the stent; therefore a premature deployment cannot be reproduced.It was not known when the user activated the deployment mechanism.System compatible introducer and guidewire were used.Based on evaluation of the delivery system and event information provided, breakage of the proximal end of the catheter as well as detachment of the stability sheath is confirmed.However, a definite root cause for the reported event could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.The instructions for use state: 'if resistance is met during stent system introduction, the stent system should be withdrawn and another stent system should be used.', and 'if resistance is met while retracting the delivery system over a guidewire, remove the delivery system and guidewire together.' the instructions for use further state: 'gain ipsilateral or contralateral femoral access utilizing an appropriate introducer sheath ¿ 5f (1.67 mm) or larger introducer sheath (.) insert a guidewire of appropriate length (table 2) and 0.014-inch (0.36 mm) - 0.035-inch (0.89 mm) diameter across the lesion to be stented via the introducer sheath.' in regard to pta the instructions for use state: 'pre-dilatation of the lesion with a balloon dilatation catheter is recommended.' in regard to damage the instructions for use state: 'examine the stent system for any damage.If it is suspected that the sterility or performance of the stent system has been compromised, the device should not be used'.H10: b5, d4 (expiry date: 01/2024), g3.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 stent placement procedure via contralateral common femoral, the outer sheath was allegedly detached.It was further reported that the green outer sheath was allegedly deformed.Reportedly, the device prematurely activated.The procedure was completed using another device.There was no reported patient injury.
|
|
Search Alerts/Recalls
|
|