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Model Number 12TLW805F35 |
Device Problem
Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/30/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Our product evaluation lab received one 12tlw805f35 catheter with attached bd 3 cc syringe.The balloon did not inflate due to air leakage from the catheter tip.Visual examination found a crack at inside of the catheter tip.The crack entered the inflation lumen.The length of crack could not be measured because it was inside of the tip.The edges of cracks did not appear to match up.Air leakage was observed from the gate valve when a leak test was performed with the thru-lumen.No other visible damages were observed from the catheter body, returned syringe, balloon and windings.A device history record review was initiated to check that the device met all specifications upon distribution.The customer report of the balloon of the fogarty catheter ruptured was not confirmed.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.
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Event Description
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It was reported that during use, the balloon of a fogarty catheter from model 12tlw805f35 and lot 64193151, ruptured.There were no patient complications reported.
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Manufacturer Narrative
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An engineering evaluation was performed to assess for any manufacturing related causes processes which could be correlated to the complaint.A capa was initiated, and corrective actions were implemented successfully.A product risk assessment escalation was not required.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.
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Search Alerts/Recalls
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