Model Number H7493912408300 |
Device Problem
Hole In Material (1293)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/30/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
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Event Description
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It was reported that shaft hole occurred.An 8mm x 3.00mm nc quantum apex¿ balloon catheter was advanced for dilation.Inflation was attempted at 12 atmospheres, however, the balloon did not inflate.The device was removed and a hole on the shaft was noted, where the contrast media leaked.The procedure was completed with another 3.0x8mm nc balloon catheter.No patient complications were reported.
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Manufacturer Narrative
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Device evaluated by mfr: returned product consisted of the nc quantum apex balloon catheter.The balloon, shaft and tip were microscopically and tactile inspected.There was contrast and blood in the inflation lumen and balloon.The balloon was loosely folded.Microscopic examination revealed that the shaft had a hole on the back side of the exit notch with deep scratches.The damage to the shaft is consistent with damage that occurs due to interaction with the guidewire.The tip was damaged.Inspection of the remainder of the device revealed no other damage or irregularities.No other issues were identified during the product analysis.The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).
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Event Description
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It was reported that shaft hole occurred.An 8mm x 3.00mm nc quantum apex balloon catheter was advanced for dilation.Inflation was attempted at 12 atmospheres, however, the balloon did not inflate.The device was removed and a hole on the shaft was noted, where the contrast media leaked.The procedure was completed with another 3.0x8mm nc balloon catheter.No patient complications were reported.
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Manufacturer Narrative
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Device evaluated by mfr: returned product consisted of the nc quantum apex balloon catheter.The balloon, shaft and tip were microscopically and tactile inspected.There was contrast and blood in the inflation lumen and balloon.The balloon was loosely folded.Microscopic examination revealed that the shaft had a hole on the back side of the exit notch with deep scratches.The damage to the shaft is consistent with damage that occurs due to interaction with the guidewire.The tip was damaged.Inspection of the remainder of the device revealed no other damage or irregularities.No other issues were identified during the product analysis.The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).
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Event Description
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It was reported that shaft hole occurred.An 8mm x 3.00mm nc quantum apex balloon catheter was advanced for dilation.Inflation was attempted at 12 atmospheres, however, the balloon did not inflate.The device was removed and a hole on the shaft was noted, where the contrast media leaked.The procedure was completed with another 3.0x8mm nc balloon catheter.No patient complications were reported.
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Search Alerts/Recalls
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