(b)(4).No lot number was reported.The lot number on the returned original packaging label is 16f21g0064.The sample returned was investigated as a representative sample.Returned for investigation was a 5fr.110cm wedge catheter with the original packaging pouch.Returned with the sample was the supplied control stroke syringe and a 0.025in guidewire.Upon return, 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.Orange media was noted in the distal end of the injection lumen.No condensation was noted in the inflation lumen extension line.No blood was noted on the interior or the exterior surfaces of the returned catheter.No damage or abnormalities were noted to the returned sample.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 4.0mm.The other side measured appro ximately 4.0mm.The balloon did meet specifications.The inflation lumen was injected with 0.75cc of air using the returned control stroke syringe.The balloon inflated symmetrically.The balloon deflated in less than 3 seconds when the syringe was removed per specification.Upon tug test, no pull away was noted.The balloon was placed in water, and air was injected into the inflation lumen again.No leak was noted.The injection lumen was aspirated and flushed.No blood or debris was noted.The returned 0.025in guidewire was back loaded through the distal tip.Resistance was noted immediately.The guidewire was able to advance through the injection lumen.No blood or debris was noted with the guidewire.The guidewire was front loaded through the injection lumen extension line.Resistance was noted at approximately 110cm from the extension line end.The guidewire was able to advance through the injection lumen.No blood or debris was noted with the guidewire.During visual inspection, orange media was noted in the distal end of the injection lumen which caused the guidewire resistance in that location.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 is acceptable.This will be monitored for any developing trends.The reported complaint of "very tight at the tip" is confirmed.A representative sample was received for the investigation.During the investigation, media was noted in the distal tip of the catheter.Upon functional testing, the guidewire encountered resistance at the distal end of the injection lumen.Based on a review of the device history record (dhr), the product met specification upon release; however, the specifications were not met during the complaint investigation due to the media in the injection lumen.The root cause of the complaint is undetermined.No further action required at this time.This will be monitored for any developing trends.
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