Catalog Number 1013065-12 |
Device Problems
Inflation Problem (1310); Leak/Splash (1354); Product Quality Problem (1506); Material Split, Cut or Torn (4008)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The device is expected to be returned for investigation.
It has not yet been received.
A follow-up report will be submitted with all additional relevant information.
The traveler device is not currently available commercially in the us; however, it is similar to a device sold in the us.
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Event Description
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It was reported that after preparation of the 2.
0x12mm traveler balloon dilatation catheter, the balloon was not in proper shape.
It was then pressurized outside of the patient, but the balloon did not hold pressure and failed to inflate.
A leak was observed from the balloon.
The procedure was then aborted.
There were no adverse patient effects and no clinically significant delay in the procedure.
No additional information was provided.
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Search Alerts/Recalls
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