Model Number 1012453-20 |
Device Problem
Deflation Problem (1149)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/01/2022 |
Event Type
malfunction
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Event Description
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It was reported that there was an issue with deflation with the 4.0x20 mm nc trek balloon dilatation catheter.There were no reported adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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The device location was not provided, and it is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.
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Manufacturer Narrative
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The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported deflation issue.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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Manufacturer Narrative
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The device was returned for analysis.The reported deflation problem was unable to be confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.As the reported deflation problem was unable to be confirmed during return analysis it is possible that interactions with the anatomy/other devices and/or the noted device damages (bunched inner and outer member) resulted in compromising the inflation/deflation lumen; thus resulting in the reported deflation problem; however this cannot be confirmed.The investigation determined a conclusive cause for the reported deflation problem cannot be determined.Interaction/manipulation of the device likely resulted in the noted bunched inner and outer member which possibly contributed to the reported deflation problem.The stretched guide wire exit notch appears to have resulted from an interaction with the guide wire.This type of mechanical damage can occur if an attempt is made to pull the stent delivery system in an opposite direction as the guide wire.The noted multiple bends on the hypotube likely occurred due to handling or during packing for return analysis.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6- type of investigation code 4115 (device discarded) was removed and replaced with code 10 (testing of actual/suspected device) investigation findings code 114 operational problem identified was removed and replaced with code 213 (no device problem found).D9 - device available for eval updated from 'no' to 'yes' h10: addtl mfg narrative ¿ updated.
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Search Alerts/Recalls
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