Model Number IPN917235 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/26/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Qn#(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
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Event Description
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"it was reported that the balloon lumen and the contrast media injection lumen got ruptured during use.Therefore, the catheter was replaced with a new one, which was inserted at the same site.The procedure was completed without problem and no harm to the patient occurred." see associated mdr 3010532612-2023-00075.
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Manufacturer Narrative
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Qn # (b)(4).The reported lot number (16f22l0062) matches the lot number on the returned original packaging pouch/label.Returned for investigation was a 5fr.80cm berman catheter with the original packaging pouch.The sample was loosely packed within the original packaging pouch.Upon return, the catheter body was immediately noted ruptured near the junction hub; the body was noted ruptured from approximately 88.9cm to 89.3cm from the distal tip of the catheter.The supplied control stroke syringe was noted connected to the inflation lumen stopcock; no damage or abnormalities were noted to the returned syringe.The inflation lumen stopcock was in the open position.The recommended volume capacity of the balloon is 0.75cc.Upon microscopic inspection, small stress marks were visible on the edges of the balloon surface.No condensation was noted within the inflation lumen extension line.No contrast media was noted within the injection lumen extension line.Spots of dried blood were noted on the exterior surfaces of the returned sample.No blood was noted within the interior surfaces of the returned sample.No other damage or abnormalities were noted.The inflation lumen was injected with 0.75cc of air using the returned control stroke syringe.The balloon inflated symmetrically.One side of the balloon measured approximately 4mm.The other side measured approximately 4mm.No pull away was noted after the tug test.The balloon was placed in water and air was injected into the inflation lumen again.No leak was noted.The damaged/ruptured catheter body did not result in damage to the inflation lumen.The catheter's injection lumen was aspirated/flushed, and air was noted leaking from the damaged/ruptured catheter body.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.The risk of the reported event is acceptable.The returned device passed visual and functional testing for the reported complaint.The reported complaint for "balloon lumen ruptured during use" is not confirmed.During the investigation, the balloon inflated as per specifications.The returned device passed visual and functional test specifications for the reported "balloon lumen ruptured" event.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.Other remarks: n/a corrected data: n/a.
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Event Description
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"it was reported that the balloon lumen and the contrast media injection lumen got ruptured during use.Therefore, the catheter was replaced with a new one, which was inserted at the same site.The procedure was completed without problem and no harm to the patient occurred." see associated mdr 3010532612-2023-00075.
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Search Alerts/Recalls
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